The Cardio10 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.

Pediatric population is defined as patients between the ages from 3 and less than 16 years.

Basic systems deliver 12 lead ECG's, interpretive analysis, and can be upgraded to provide software analysis options such as a high resolution signal averaging of QRS and P wave portions of the electrocardiogram. 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.

Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The Cardio10 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

Cardio10 is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients. 5 years and older, in general practice, specialty physician, and hospital settings. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, COPD, SVC, MVV.

Device Description

Cardio 10 is a device to measure and record ECG of a patient as an ECG recording machine with 12 channels.

It provides parameters required for the diagnosis. ECG records of a patient, and automatic diagnosis and prints ECG records and output report if entering patient or user information and efficiently use them for the chart management. At the same time, it is possible to transmit saved data to the PC connected to the network and manage digital files.

In addition, it is possible to measure ECG by pressing the button only once in consideration of the convenience of a user as much as possible and save, transmit, and print data all at once after completing the automatic diagnosis.

Parameter and automatic diagnosis required on the spirometer record and diagnosis of patients are provided to users while printing the A4 size and Letter size report along with the spirometer records by entering the information of patients or users for the efficient management of chart. At the same time, saved data are delivered to the PC connected to the network managing digital files.

In addition, the battery can be internally saved as an optional component making it feasible to carry and use for checkup while moving.

AI/ML Overview

The provided document is a 510(k) summary for the Cardio10 device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results in the same way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain the kind of detailed information about acceptance criteria for device performance, the specific study design (beyond general non-clinical testing for safety and EMC), sample sizes for test sets where ground truth was established, expert qualifications, or multi-reader multi-case studies as you requested.

The document states: "Clinical testing is not required." This indicates that the manufacturer did not conduct a clinical study to prove the device meets specific performance acceptance criteria in human subjects for the purpose of this 510(k) submission.

However, based on the information provided, I can extract the following details regarding the non-clinical testing performed to support substantial equivalence:

Acceptance Criteria and Device Performance (Non-Clinical Testing Summary)

The Cardio10 device was tested to comply with several international and national standards related to electrical safety, electromagnetic compatibility, usability, and specific requirements for electrocardiographs and spirometers. The acceptance criteria essentially refer to meeting the requirements of these standards. The device is reported to comply with these standards.

Acceptance Criteria (Standard Compliance)	Reported Device Performance
IEC 60601-1:2005/AMD1:2012 (General requirements for basic safety and essential performance)	Complies
IEC 60601-1-2:2014 (EMC requirements)	Complies
IEC 60601-1-6:2010 (Usability)	Complies
IEC 60601-2-25: 2011 (Particular requirements for the safety of electrocardiographs)	Complies
ISO 26782:2009 (Spirometers for time forced expired volumes)	Complies
ISO 23747:2009 (Peak expiratory flow meters)	Complies
ANSI AAMI EC53 (Specific to ECG, but general mention without specific details)	Complies
Software Validation (Major level of concern firmware, developed according to a software development process, verified and validated)	Verified and Validated
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous reactivity tests based on EN ISO 10993-5, EN ISO 10993-10, ISO 10993-10)	Complies (contents prepared by being referenced standards)

Missing Information:

The document does not provide the following information as it was not a clinical study designed to demonstrate performance against specific clinical acceptance criteria:

Sample size used for the test set and data provenance: Not applicable for the non-clinical validation studies described.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable for the non-clinical validation studies described.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was conducted. The document explicitly states "Clinical testing is not required."
Standalone (algorithm only without human-in-the-loop performance): While the device includes interpretive algorithms, the document does not provide a specific standalone performance study report for these components. The claim is substantial equivalence to a predicate device that also has interpretive analysis, and that algorithm analysis "must be confirmed by a physician."
Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for the non-clinical validation studies described.
Sample size for the training set: Not applicable, as this is not a study about an AI model's training performance, but rather a regulatory submission for a device incorporating software.
How the ground truth for the training set was established: Not applicable.

Summary of what the document does indicate regarding "studies":

The "study" that proves the device meets the (non-clinical) acceptance criteria consists of various engineering and validation tests to demonstrate compliance with recognized national and international standards for electrical safety, electromagnetic compatibility, usability, and specific device types (ECG and spirometer). Software validation was also performed, indicating that the firmware was developed, verified, and validated according to a software development process. Biocompatibility testing was also conducted. These are all non-clinical evaluations aimed at establishing safety and performance relative to predicate devices and recognized standards, but they are not clinical trials demonstrating diagnostic accuracy or effectiveness in human subjects with specific clinical endpoints.

Summary

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November 15, 2022

Bionet Co., Ltd. Kyungeun Park Assistant Manager 5F, 61 Digital-ro 31 gil, Guro-gu Seoul. 08375 South Korea

Re: K220535

Trade/Device Name: Cardio10 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, BZG Dated: October 12, 2022 Received: October 12, 2022

Dear Kyungeun Park:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shruti N. Mistry -S

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K220535

Device Name Cardio10

Indications for Use (Describe)

The Cardio10 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.

Pediatric population is defined as patients between the ages from 3 and less than 16 years.

Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The Cardio10 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a sans-serif font, with the "b" in lowercase and the rest of the letters in lowercase as well. Above the word "bionet" is a stylized butterfly with blue wings. The butterfly is positioned slightly to the left of the word "bionet".

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

February 18, 2022

Submitter's Information [21 CFR 807.92(a)(1)] 2.

Name of Manufacturer: Bionet Co., Ltd.
Address: 5F, 61 Digital-ro 31 gil, Guro-gu, Seoul, Republic of Korea 08375
Contact Name: Kyungeun Park / Assistant Manager
Telephone No.: +82-2-6292-6410 ●
Fax No.: ● +82-2-6499-7788
Email Address: ● kepark@ebionet.com
Registration No.: 3003681187

Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)] 3.

Trade/Device Name	Cardio10
Common Name	Electrocardiograph & Spirometer
Regulation Number	870.2340 / 868.1840
Regulation Name	Electrocardiograph / Diagnostic spirometer
Regulation Class	2
Product Code	DPS / BZG

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Image /page/4/Picture/0 description: The image shows the logo for Bionet. The logo features the word "bionet" in a sans-serif font, with the "b" in lowercase and the rest of the letters in lowercase. Above the word "bionet" is a stylized butterfly in a light blue color. The butterfly is positioned so that it appears to be flying upwards and to the right.

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow;

Predicate device

510(k) Number: K113306 ●
Applicant: Bionet Co., Ltd. ●
Trade/Device Name Cardio7
Regulation Number 870.2340
Electrocardiograph Regulation Name:

Regulation Class:
. DPS Product Code:

Reference device

. 510(k) Number: K130322
Applicant: Bionet Co., Ltd.
Trade/Device Name SPM-300
Regulation Number 868.1840
Regulation Name: Diagnostic spirometer
Regulation Class: 2
Product Code: BZG ●

The predicate device and reference device has not been subject to a design-related recall.

5. Description of the Device [21 CFR 807.92(a)(4)]

Cardio 10 is a device to measure and record ECG of a patient as an ECG recording machine with 12 channels.

In addition, the battery can be internally saved as an optional component making it feasible to carry and use for checkup while moving.

K220535 Page 2 / 8

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Image /page/5/Picture/0 description: The image shows the logo for Bionet. The logo features the word "bionet" in a sans-serif font, with the "b" in lowercase and the rest of the letters in lowercase. Above the word "bionet" is a stylized butterfly with a light blue color. The butterfly is positioned so that it appears to be flying upwards and to the right.

6. Indications for use [21 CFR 807.92(a)(5)]

The Cardio10 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.

Pediatric population is defined as patients between the ages from 3 and less than 16 years.

Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The Cardio10 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

Cardio10 is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients, 5 years and older, in general practice, specialty physician, and hospital settings. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, COPD, SVC, MVV.

7. Determination of Substantial Equivalence

The Cardio10 is substantially equivalent to legally marketed predicate devices with respect to indications for use and technology characteristics.

	Subject Device	Predicate Device
Product Name	Cardio10	Cardio7
510(k) Number	K220535	K113306
Manufacturer	Bionet Co., Ltd.	Bionet Co., Ltd.
Product Code	DPS	DPS
Device Class	2	2
Indications forUse	The Cardio10 ECG Analysis System isintended to acquire, analyze, display,and record electrocardiographicinformation from adult and pediatricpopulations. Pediatric population isdefined as patients between the agesfrom 3 and less than 16 years.Basic systems deliver 12 lead ECG's,interpretive analysis, and can beupgraded to provide softwareanalysis options such as a highresolution signal averaging of QRS	Cardio7 is intended for use as adiagnostic tool by trained operatorsin health facilities. It provides thefollowing functions:• Acquire ECG waveform data fromup to twelve (12) leads throughsurface electrodes adhered to thepatient's body.• Input patient data.• View, store and print captureddata.
	Subject Device	Predicate Device
	and P wave portions of theelectrocardiogram. The 12-lead ECGinterpretive algorithm provides acomputer-generated analysis ofpotential patient cardiacabnormalities, which must beconfirmed by a physician with otherrelevant clinical information.Transmission and reception of ECGdata to and from a central ECGcardiovascular information system isoptional.The Cardio10 is intended to be usedunder the direct supervision of alicensed healthcare practitioner, bytrained operators in a hospital ormedical professional's facility.Cardio10 is intended forprescription use only to conductdiagnostic spirometry testing ofadults and pediatric patients, 5 yearsand older, in general practice,specialty physician, and hospitalsettings. The device is intended to beused as a spirometer whichmeasures patient respiratoryparameters including FVC, COPD,SVC, MVV.	• Analyze captured data; displayand print analysis results.• Retain captured data and analysisresults for up to 120 patients.• Transfer retained data to a PC(via server IP) or directly toinsertable USB memory.
TargetPopulation	Adult and pediatric patients	Adult and pediatric patients
ECG Leads	Simultaneous 12 channel ECG andacquisition	Simultaneous 12 leads resting ECGconnect directly to Cardio7 systemunit
Gain	2.5, 5, 10, 20, Auto (I~~aVF: 10,V1~~V6: 5) mm/mV	2.5, 5, 10, 20, auto(I~~aVF: 10,V1~~V6: 5) mm/mV
Sampling Rate	Analysis Sampling Rate – 500HzDigital Sampling Rate -8,000Hz	500 samples/sec/channel
Filters	AC (50/60 Hz, -20dB or better),Muscle (25~35Hz, -3dB or better),Base line drift (0.05Hz, 0.1Hz, 0.2Hz,-3dB or better),	AC (50/60 Hz, -20dB or better),Muscle (25~35Hz, -3dB or better),Base line drift (0.1Hz, -3dB or better),
	Subject Device	Predicate Device
	Low pass filter(off, 40Hz, 100Hz,150Hz)	Low pass filter(off, 40Hz, 100Hz,150Hz)
Patient data	ID, Name, Birthday, Age, Gender,Height, Weight, Race, Smoke,Department, Room no., Study desc.,Accession No.,Referring Physician	ID, Name, Age, Gender, Height,Weight, Race, Smoke
BasicMeasurement	Heart rate(30~300bpm ±3), PR/RRint., QRS dur., QT/QTc int.,P-R-T axis, SV1/RV5/R+S amp.	Heart rate, PR int, QRS dur, QT/QTc,P-R-T axis
Battery	10 hours of normal use or print 350ECG(12 channel format at 25mm/sand 10mm/mV) or Spiro pages.Battery recharge to full capacity in3hours. (The device is turned off)	1 hours of normal use or print 100ECG pages.Battery recharge to full capacity in4hours. (The device is turned off)
Data storage	Internal Storage for 500 data : Builtin memory	Internal Storage for up to 120 ECGAdditional storage available usingbuilt in SD RAM slot
Dimension	300(W) x 299(H) x 123(D) mm(monitor tilt down)300(W) x 299(H) x 237(D) mm(monitor tilt up)Approx.4kg(Main Body)	296 x 305 x 92 mmApprox. 3.5kg

Comparison of Subject Device to Predicate Device K113306

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Image /page/6/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized blue butterfly above the word "bionet" in a sans-serif font. The butterfly is a light blue color and appears to be in flight. The word "bionet" is in black and is written in lowercase letters.

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Image /page/7/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized butterfly in a light blue color, positioned above the word "bionet" in a bold, black sans-serif font. The butterfly is designed with three distinct sections, resembling wings, and is oriented towards the upper left.

Comparison of Subject Device to Reference Device K130322

	Subject Device	Reference Device
Product Name	Cardio10	SPM-300
510(k) Number	K220535	K130322
Manufacturer	Bionet Co., Ltd.	Bionet Co., Ltd.
Product Code	DPS	BZG
Device Class	2	2
Indications forUse	The Cardio10 ECG Analysis System isintended to acquire, analyze, display,and record electrocardiographicinformation from adult and pediatricpopulations. Pediatric population isdefined as patients between the agesfrom 0 and less than 16 years.Basic systems deliver 12 lead ECG's,interpretive analysis, and can beupgraded to provide software	The SPM-300 Spirometer is intendedfor prescription use only to conductdiagnostic spirometry testing ofadults and pediatric patients ingeneral practice, specialty physician.and hospital settings.
	Subject Device	Reference Device
	analysis options such as a highresolution signal averaging of QRSand P wave portions of theelectrocardiogram. The 12-lead ECGinterpretive algorithm provides acomputer-generated analysis ofpotential patient cardiacabnormalities, which must beconfirmed by a physician with otherrelevant clinical information.Transmission and reception of ECGdata to and from a central ECGcardiovascular information system isoptional.The Cardio10 is intended to be usedunder the direct supervision of alicensed healthcare practitioner, bytrained operators in a hospital ormedical professional's facility.Cardio10 is intended forprescription use only to conductdiagnostic spirometry testing ofadults and pediatric patients, 5 yearsand older, in general practice,specialty physician, and hospitalsettings. The device is intended to beused as a spirometer whichmeasures patient respiratoryparameters including FVC, COPD,SVC, MVV.
TargetPopulation	Adult and pediatric patients	Adult and pediatric patients
Measuringvalues	- FVC : FVC, FEV1, FEV1/FVC, FEF0.2-1.2L, FEF 25-75%, FEF 75-85%,PEF, FEF 25%, FEF 50%, FEF 75%,FIVC, FEV6, PEFT, FET 100%, ErrorCode, Extrapolation volume- COPD : FEV1, FEV6, FEV1/FEV6, LFI- SVC : SVC, TV, ERV, IRV, EC- MVV : MVV, FB, TV	- FVC : FVC, FEV1, FEV1/FVC, FEF 0.2-1.2L, FEF 25-75%, FEF 75-85%, PEF,FEF 25%, FEF 50%, FEF 75%,- SVC : SVC, TV, ERV, IRV, EC, IC, RV- MVV : MVV, FB, TV
Presentation	Flow Volume loopVolume Time GraphMeasurement values table	Volume/Time curveFlow/Volume curveMeasurement Values Table
	Subject Device	Reference Device
Measuring range	Flow : 0 to 14 L/sVolume : 0 to 12 L	Flow : 0 to ± 14 L/sVolume : 0 to + 11 L
Measuringmethod	Differential pressure method	Differential pressure method
Measuringaccuracy	Complies with ISO26782 andISO23747	Complies with ISO26782 andISO23747

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Image /page/8/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized butterfly in a light blue color, positioned above the word "bionet" written in a bold, black sans-serif font. The butterfly has a simple, modern design, and the overall logo has a clean and professional appearance.

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Image /page/9/Picture/0 description: The image shows the logo for "bionet". The logo features the word "bionet" in a sans-serif font, with the letters in black. Above the word "bionet" is a stylized butterfly in a gradient of blue. The butterfly is positioned to the left of the word, giving the logo a clean and modern look.

The Cardio 10 and predicate devices are similar in their target population, functions, technical characteristics includes ECG leads, Gain, Sampling rate, measurement, etc.

Differences between Cardio10 and the predicate device such as base line drift of filter, type of patient data, measuring range, and dimension do not raise any new concerns with respect to safety or effectiveness. The subject device and predicate device are designed to meet the IEC 60601-2-25, ISO 26782, ISO 23747.

Non-Clinical Test Summary

1 ) Electrical Safety, Electromagnetic Compatibility and Performance:
The Cardio 10 comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
Testing to confirm compliance with IEC 60601-1:2005/AMD1:2012 ● Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. Testing to confirm compliance with IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
Testing to confirm compliance with IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Testing to confirm compliance with IEC 60601-2-25: 2011 . Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
Testing to confirm compliance with ISO 26782:2009 Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans
. Testing to confirm compliance with ISO 23747:2009 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the

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Image /page/10/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a lowercase, sans-serif font. Above the word is a stylized butterfly in a light blue color. The butterfly is positioned so that it appears to be flying above and slightly to the right of the word "bionet".

assessment of pulmonary function in spontaneously breathing humans

ANSI AAMI EC53
1. Software Validation

The Cardio10 contain Major level of concern software as firmware. The software was designed and developed according to a software development process and was verified and validated.

Software information is provided in accordance with FDA guidance:

Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices: Guidance for Industry and FDA Staff
Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
1. Biocompatibility

Most of the contents are prepared by being referenced the following standards:

Cytotoxicity test by EN ISO 10993-5 ●
Sensitization test by EN ISO 10993-10
Intracutaneous reactivity test by ISO 10993-10 ●

#95-1 Biocompatibility Flow Chart for Selection of Toxicity tests for 510(k)s, FDA.

Clinical Test Summary

Clinical testing is not required

8. Substantial Equivalence [21 CFR 807.92(b)[1] and 807.92]

The non-clinical testing demonstrates the subject device (Cardio10) is substantially equivalent in terms of technological characteristics to the predicate device (K113306) and reference device (K130322).

9. Conclusion [21 CFR 807.92(b)(3)]

The Cardio10 has similar intended use and technical characteristics to the predicate device. Based on the information summarized above, the Cardio10 is substantially equivalent to the predicate device and does not raise any new questions regarding safety or effectiveness.

Regulation Number and Section

§ 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).