(90 days)
No
The document describes a traditional interpretive algorithm (MEANS algorithms) which was validated in 1996 and is based on established standards (IEC 60601-2-51, ATS). There is no mention of AI, ML, training data, or adaptive learning.
Yes
The device is described as an electrocardiograph and spirometry module used to evaluate, diagnose, and monitor patient cardiac and pulmonary function, which are therapeutic purposes.
Yes
The device explicitly states its intended use is to "evaluate, diagnose, and monitor patient cardiac function" and to "assess a patient's pulmonary health status and evaluate symptoms, signs, or abnormal laboratory test results," indicating a diagnostic purpose.
No
The device description explicitly details hardware components such as a full alphanumeric keyboard, LCD/color display, memory card compatibility, battery/AC power operation, and an interface to a pulmonary function device. While it includes software for interpretation and data management, it is integrated into and dependent on the described hardware.
Based on the provided text, the Welch Allyn CP 100™ and CP 200™ electrocardiographs are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The text clearly states that these devices acquire and print ECG signals directly from adult and pediatric patients. They are measuring electrical activity within the body, not analyzing a sample taken from the body.
- The intended use and device description focus on acquiring and analyzing physiological signals (ECG and spirometry) from the patient. This is characteristic of in vivo diagnostic devices, not in vitro ones.
- The optional interpretation algorithm analyzes the ECG signals, which are directly acquired from the patient. While this analysis provides information about potential cardiac abnormalities, it is based on in vivo measurements.
Therefore, these devices fall under the category of in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
The optional Spirometry module is indicated for use in clinical situations to assess a patient's pulmonary health status and evaluate symptoms, signs, or abnormal laboratory test results.
Product codes
DPS, BZG
Device Description
The Welch Allyn CP 100TM electrocardiograph features a full alphanumeric key board, an LCD display, full-size user-programmable reports, and the ability to operate on either battery or AC power. ECG tests sent to a memory card are compatible with the Welch Allyn CardioPerfect™ workstation, which in turn can connect with other electronic patient-information systems, such as billing and medical records. The CP 100™ electrocardiograph is specifically intended for acquiring and printing ECG signals from adult and pediatric patients. It will be used in clinical settings by trained healthcare providers. The optional interpretation algorithm analyzes these ECG signals to generate measurements and interpretive statements. The interpretive results are intended only as guidance for qualified physicians and must not be relied upon as diagnoses.
The Welch Allyn CP 200™ electrocardiograph can display, print, save, and send ECGs electronically. It features a full alphanumeric keyboard, a color display to preview ECGs and edit settings, storage for up to 50 ECG and 50 spirometry records, full-size user programmable reports, and the ability to operate on either battery or AC power. For centralized ECG data storage, the CP 200™ electrocardiograph can connect to a Welch Allyn CardioPerfect™ workstation, which in turn can connect with other electronic patient-information systems, such as billing and medical records. The CP 200 electrocardiograph is specifically intended for acquiring, viewing, storing, and printing ECG signals from adult and pediatric patients. It will be used in clinical settings by trained health care providers. The optional interpretation algorithm analyzes these ECG signals to generate measurements and interpretive statements. The interpretive results are intended only as guidance for qualified physicians and must not be relied upon as diagnoses. The electrocardiograph provides and optional interface to a pulmonary function device. Communication of ECG and spirometry data with a central data-management system is optional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardio (heart), Pulmonary (lungs)
Indicated Patient Age Range
Adult and pediatric patients.
Intended User / Care Setting
Trained operators in healthcare facilities / clinical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The implementation of the MEANS interpretive software in the CP 100™ and CP 200™ electrocardiographs device, and its performance, is equivalent in every respect to the implementation of this software in the CardioPerfect™ with MEANS device submitted to the agency by Cardio Control BV (= Welch Allyn acquired Cardio Control BV) and cleared per K962854. Both of these product families have implemented the 1996 version of the MEANS algorithms. The Department of Medical Informatics of Erasmus University Rotterdam independently validated the MEANS algorithms in 1996. A copy of the specificity and sensitivity from that study, as presented for the Welch Allyn CardioPerfect™ with MEANS submission K962854.
The MEANS algorithms were verified and found to be consistent with the requirements of IEC 60601-2-51:2003, particular requirements for safety, including essential performance, of recording and analyzing single channel and multi-channel electrocardiographs.
The spirometry functionality of the CP 200™, including the custom software, was validated by Robert O. Crapo, M.D., Medical Director of the pulmonary Laboratory at LDS Hospital in Salt Lake City, Utah. He performed testing using the standard "Standardization of Spirometry: 1994 Update and 2005 version" published by the Americal Thoracic Society (ATS). The test report issued by Dr. Crapo's laboratory -LDS Hospital, dated March 2, 2007, the CP 200™ device meets all stated accuracy and precision requirements defined in the ATS standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity and sensitivity data mentioned for MEANS algorithms, however, specific values are not provided in the summary, only the reference to where they were presented (K962854).
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
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WelchAllyn
Abbreviated 510(k)
Section 5 – 510(k) Summary
510(k) Summary
[As described in 21 CFR 807.92]
| Submitted by: | Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls, NY 13153-0220 | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | John Sawyer
Vice President, QA/RA
Phone: (315) 685-4571
Fax: (315) 685-2532
E-mail: sawyerj@welchallyn.com | NOV 2 9 2007 |
| Date Prepared: | August 24, 2007 | |
| Trade Name: | Welch Allyn CP 100TM and CP 200TM Electrocardiographs | |
| Common Name: | Electrocardiograph | |
| Classification Reference: | Class II, Electrocardiograph (21 CFR 870.2340, Product
Code DPS) and Diagnostic Spirometer (21 CFR 868.1840,
Product Code BZG) | |
| Predicate Device: | PageWriter Trim Series Cardiograph
Philips Medical Systems
510(k) Number: K001265
Electrocardiograph, 21 CFR 870.2340
Class II, DPS
Medikro D9 Spirometer
Caird Technology Inc
510(k) Number: K031422
Diagnostic Spirometer, 21 CFR 868.1840
Class II, BZG | |
1
Description of the Device:
The Welch Allyn CP 100TM Electrocardiograph:
The Welch Allyn CP 100™ electrocardiograph features a full alphanumeric key board, an LCD display, full-size user-programmable reports, and the ability to operate on either battery or AC power.
ECG tests sent to a memory card are compatible with the Welch Allyn CardioPerfect™ workstation, which in turn can connect with other electronic patient-information systems, such as billing and medical records.
The CP 100™ electrocardiograph is specifically intended for acquiring and printing ECG signals from adult and pediatric patients. It will be used in clinical settings by trained healthcare providers.
The optional interpretation algorithm analyzes these ECG signals to generate measurements and interpretive statements. The interpretive results are intended only as guidance for qualified physicians and must not be relied upon as diagnoses.
Image /page/1/Picture/9 description: The image shows a piece of office equipment, possibly a printer or a fax machine. The device has a keyboard on the front and a display screen on the right side. The device appears to be white or light gray in color. The image is a black and white photograph.
Welch Allyn CP 100™
Image /page/1/Picture/11 description: The image shows a central hub with multiple cables extending outwards. The hub is light-colored and has a curved design. Several of the cables are bundled together with a band, while others are individual and coiled. The cables terminate in various connectors, including what appears to be a VGA connector and several audio jacks.
The Welch Allyn CP 200TM Electrocardiograph:
The Welch Allyn CP 200™ electrocardiograph can display, print, save, and send ECGs electronically. It features a full alphanumeric keyboard, a color display to preview ECGs and edit settings, storage for up to 50 ECG and 50 spirometry records, full-size user programmable reports, and the ability to operate on either battery or AC power.
For centralized ECG data storage, the CP 200™ electrocardiograph can connect to a Welch Allyn CardioPerfect™ workstation, which in turn can connect with other electronic patient-information systems, such as billing and medical records.
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WelchAllyn
The CP 200 electrocardiograph is specifically intended for acquiring, viewing, storing, and printing ECG signals from adult and pediatric patients. It will be used in clinical settings by trained health care providers.
The optional interpretation algorithm analyzes these ECG signals to generate measurements and interpretive statements. The interpretive results are intended only as guidance for qualified physicians and must not be relied upon as diagnoses.
The electrocardiograph provides and optional interface to a pulmonary function device.
Communication of ECG and spirometry data with a central data-management system is optional.
Image /page/2/Picture/6 description: The image shows a Welch Allyn CP 200 electrocardiograph machine. The machine has a keyboard, a display screen, and a printer. The machine is white and has a black printer on the left side. The machine is used to record the electrical activity of the heart.
Image /page/2/Picture/7 description: The image shows the text "Welch Allyn CP 200". The text is in a simple, sans-serif font and is left-aligned. The letters are black, and the background is white. The number 200 has a superscripted "T 1/2".
Image /page/2/Picture/8 description: The image shows a collection of white cables and connectors against a black background. The cables are arranged in a radial pattern, emanating from a central hub or connector. Some of the cables are coiled, while others are straight, and they all appear to be interconnected through the central hub.
Intended Use:
The Welch Allyn Electrocardiography and Spirometry Products (Subject Devices) are intended for use by trained operators in health facilities. The subject devices provide the following diagnostic functions:
- Acquiring, viewing, storing and printing ECG waveforms using ECG Front End . Modules and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.
- Using optional algorithms to generate measurements, data presentations, graphical . presentations and interpretative statements on an advisory basis. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the result of physical examination, the ECG tracings and other clinical findings.
- Using the optional Spirometry module and associated accessories to acquire, view, . store and print measures and waveforms of pulmonary function including, but not limited to, maximal volume and flow of air that can be moved in and out of the patient's lungs. These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases. The
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spirometer should only be used with patients able to understand the instructions for performing the test.
Indications for Use:
The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
The optional spirometry module is indicated for use in clinical situations to assess a patient's pulmonary health status and evaluate symptoms, signs, or abnormal laboratory test results.
Technological Characteristics:
The Welch Allyn Electrocardiography and Spirometry Products are intended for use by trained operators in healthcare facilities.
The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
The optional spirometry module is indicated for use in clinical situation to assess a patient's pulmonary health status and evaluate symptoms, signs, or abnormal laboratory test results.
The following table summarizes the similarities between the subject Welch Allyn CP 100™ and CP 200™ Electrocardiographs and the predicate Philips PageWriter Trim Series Cardiograph (K031422) and Caird Technology Medikro D9 Spirometer (K971336).
| Designation | Philips Medical Systems
PageWriter Trim Series Cardiograph
(Trim II) | Welch Allyn Medical Systems
CP Series Electrocardiographs (Model CP200) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating Principle | Electrocardiographs | Electrocardiographs |
| Display | Monochrome display | Color LCD:
View and adjust the ECG waveforms.
With spirometry option, also view patients' spirometry
efforts and results. |
| Keyboard | Full alphanumeric keyboard | Full alphanumeric keypad |
| ECG Storage | Storage for 50 ECGs | Storage for up to 50 ECG and 50 Spirometry records |
| Designation | Philips Medical Systems
PageWriter Trim Series Cardiograph
(Trim II) | Welch Allyn Medical Systems
CP Series Electrocardiographs (Model CP200) |
| Battery Operation | - Typically 40 ECGs on a single charge or 30 minutes of
continuous rhythm recording and no fail operation during
ECG printing.
- Battery recharge – eight hours to full capacity. | - Use the electrocardiograph almost anywhere. On
battery power, 4hours of continuous use or continuous
printing of 100 ECG pages. The continuous test is
based on performing 5 ECG's in a period of 4 hours. - Battery recharge – 12 hours to full capacity. |
| Power | The electrocardiograph can run on AC or battery power. | The electrocardiograph can run on AC or battery
power. |
| Printer | Thermal printer (internal) | Thermal printer (internal) |
| Sterility | Wipe the external surfaces of the cardiograph with a soft
cloth dampened in any of the approved cleaning solutions
listed below:
Mild soap and water
Isopropyl alcohol
Disinfect the patient cable. Use a damp soft cloth with one
of the disinfectants or cleaning agents listed below.
Cidex Ortho Phthaladehyde
Cetylcide
Vesphene 2 Aqueous Phenolic Germicidal Agent | Wipe the exterior of the patient cable and
electrocardiograph and with a damp cloth using mild
detergent diluted in water.
Disinfect the patient cable. Use a damp cloth of
chemical disinfectants containing one of the following:
ethanol (70% - 80%)
propanol (70% - 80%)
aldehydes (2% - 4%) |
| Safety | Testing to applicable standards:
• AAMI EC11
• IEC 60601-1
• UL 2601.1
• IEC 60601-2-25
• IEC 60601-1-2 | Recognized and applicable standards:
• EC11 (AAMI/ANSI)
• UL 60601-1
• IEC 60601-1
• IEC 60601-1-1
• IEC 60601-1-2
• IEC 60601-1-4
• IEC 60601-2-25
• IEC 60601-2-51 |
| Weight | 16.3 lb | 11.6 lb |
| Dimensions | 15.3 x 12.2 x 6.9 in | 16.2 x 15.6 x 6.2 in |
| Filters | > AC noise
Artifact
High and low pass | > 0.5 Hz high-performance baseline filter
35 Hz muscle-tremor filter
AC interference filter |
| ECG Acquisition | ECG signal acquisition of up to 12 leads | ECG signal acquisition of up to 12 leads |
| Network Connection | 10 Base-T Ethernet LAN card | Wireless |
| Fax | Support for PCMCIA fax modem | None |
| Modem | V.90, K56flex | None |
| Spirometry | None | Support for Spirometry
(K971336 - Medikro D9 Spirometer) |
| Indication for Use | Where the clinician decides to evaluate the
electrocardiogram of adult and pediatric patients as part of
decisions regarding possible diagnosis, potential treatment,
effectiveness of treatment or to rule-out causes for
symptoms. | The electrocardiograph is one of the tools that
clinicians use to evaluate, diagnose, and monitor
patient cardiac function. The 12-lead ECG interpretive
algorithm provides a computer-generated analysis of
potential patient cardiac abnormalities, which must be
confirmed by a physician with other relevant clinical
information. The optional spirometry module is
indicated for use in clinical situations to assess a
patient's pulmonary health status and evaluated
symptoms, signs, or abnormal laboratory test results. |
| Designation | Philips Medical Systems
PageWriter Trim Series Cardiograph
(Trim II) | Welch Allyn Medical Systems
CP Series Electrocardiographs (Model CP200) |
| Target Population | Adult and pediatric patients. | - Resting ECG: Adult and pediatric patients.
- Resting ECG Interpretation: Adult and pediatric
patients. - Spirometry: Adult and pediatric patients. |
| Where Used | Healthcare facilities | Healthcare facilities |
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WelchAllyn
长072449
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Image /page/5/Picture/0 description: The image shows the logo for Welch Allyn. The text is in a bold, sans-serif font. The logo is simple and recognizable.
Abbreviated 510(k) Section 5 - 510(k) Summary
K072449 2617
| Subject Area | Caird Technology Inc.
Medikro D9 Spirometer | Welch Allyn Medical Systems
CP Series Electrocardiographs (CP200)
Spirometer |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Number | K971336 | OEM Device (Medikro D9 Spirometer - K971336) |
| Target Population | Adult and pediatric patients. | Spirometry: Adult and pediatric patients. |
| Where Used | Hospital and Clinic use only | Healthcare facilities |
| Indication for Use | Some of the conditions for use are as follows:
• Shortness of Breath
• Chronic Cough
• Occupational Exposure to Dust or Chemicals
• Assist in the Diagnosis of Bronchitis
• Assist in the Diagnosis of Asthma
• Wheezing
• Assist in the monitoring of Bronodialators | The optional spirometry module is indicated for use in
clinical situations to assess a patient's pulmonary
health status and evaluate symptoms, signs, or
abnormal laboratory test results. |
The Welch Allyn CP 100™ and CP 200™ Series electrocardiograph/spirometry has equivalent electrocardiograph characteristics as the Philips PageWriter Trim Series and Medikro D9 Spirometer.
The technological differences do not affect the safety or effectiveness of the device.
Summary of Effectiveness:
The Welch Allyn CP Series team has determined that the software "Level of Concern" is Moderate. (See section 10 for CP 100™ & CP 200™ software Level of Concern)
The implementation of the MEANS interpretive software in the CP 100™ and CP 200™ electrocardiographs device, and its performance, is equivalent in every respect to the implementation of this software in the CardioPerfect™ with MEANS device submitted to the agency by Cardio Control BV (= Welch Allyn acquired Cardio Control BV) and cleared per K962854. Both of these product families have implemented the 1996 version of the MEANS algorithms. The Department of Medical Informatics of Erasmus University Rotterdam independently validated the MEANS algorithms in 1996. A copy
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Welch Allyn
of the specificity and sensitivity from that study, as presented for the Welch Allyn CardioPerfect™ with MEANS submission K962854.
The MEANS algorithms were verified and found to be consistent with the requirements of IEC 60601-2-51:2003, particular requirements for safety, including essential performance, of recording and analyzing single channel and multi-channel electrocardiographs.
All requirements of the recognized and applicable standards are in compliance: EC11 (AAMI/ANSI), UL 60601-1, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-25 and IEC 60601-2-51.
As a point of clarification, only the CP 200™ product will include spirometry functionality. The CP 200™ uses the same flow transducer, signal-conditioning electronics and tubing as the Medikro D9 Spirometer (K971336); all of the components external to the personal computer of the Medikro D9. The CP 200™ makes use of its embedded computer in place of the personal computer used in the Medikro D9. Because the user interface, display and embedded computer differ from that of the Medikro D9, the CP 200™ requires custom software to provide the functionality of the Spiro2000 software provided with the Medikro D9.
The spirometry functionality of the CP 200™, including the custom software, was validated by Robert O. Crapo, M.D., Medical Director of the pulmonary Laboratory at LDS Hospital in Salt Lake City, Utah. He performed testing using the standard "Standardization of Spirometry: 1994 Update and 2005 version" published by the Americal Thoracic Society (ATS). The test report issued by Dr. Crapo's laboratory -LDS Hospital, dated March 2, 2007, the CP 200™ device meets all stated accuracy and precision requirements defined in the ATS standard.
Additionally, risk management (risk, SFMEA and safety analysis) activities have been conducted in accordance with ISO 14971 Medical Devices - Application of risk management to medical devices and comply with IEC 60601-1-4 Medical Electrical Equipment Part 1: General Requirements for Safety, Part 4: Programmable Electrical Medical Systems.
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Image /page/7/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus.
Public Health Service
NOV 2 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Welch Allyn, Inc. c/o Mr. John Sawyer Vice President, QA/RA 4341 State Street Road Skaneateles Falls, NY 13153-0220
Re: K072449
Welch Allyn CP 100™ and CP 200™ Electrocardiographs Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS and BZG Dated: October 22, 2007 Received: October 24, 2007
Dear Mr. Sawyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. John Sawyer
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blyminston for
Bram &. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/9/Picture/0 description: The image shows a handwritten string of characters, "K072449". The characters are written in a casual, slightly uneven style, suggesting they were written quickly. The numbers are clearly distinguishable, and the letter 'K' is capitalized.
Indications for Use Statement
510(k) Number (if known): K072449
Device Name: Welch Allyn CP 100™ and CP 200™ Electrocardiographs
Indications for Use:
The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
The optional Spirometry module is indicated for use in clinical situations to assess a patient's pulmonary health status and evaluate symptoms, signs, or abnormal laboratory test results.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K072449 |
Welch Allyn CP100™ & CP200™