(152 days)
The Model 3230 Finger Pulse oximeter is a small, lightweight portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot checking of adult and pediatric patients on digits between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick.
Model 3230 Bluetooth® Smart Pulse oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LCD display contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate if poor pulse quality that may affect the readings. All associated electronics and the microcontrollers are within the sensor, which is activated by placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.
Here's a breakdown of the acceptance criteria and study information for the Nonin Model 3230 Pulse Oximeter, based on the provided document:
Acceptance Criteria and Device Performance
| Category | Acceptance Criteria (Predicate Device) | Reported Device Performance (Nonin Model 3230) |
|---|---|---|
| SpO2 Range | 0% to 100% SpO2 | 0% to 100% SpO2 |
| Pulse Rate Range | 18-321 BPM | 18-321 BPM |
| SpO2 Accuracy | ±2 digits (±1 Arms) | ±2% (Arms) over 70-100% SaO2 (finger/thumb) |
| Low Perfusion SpO2 Accuracy | ±2 digits (±1 Arms) | ±2% (Arms) (implied to meet) |
| Pulse Rate Accuracy | 20 to 250 BPM ±3 digits | 20 to 250 BPM ±3 digits (implied to meet) |
| Low Perfusion Pulse Rate | 40 to 240 BPM ±3 digits | 40 to 240 BPM ±3 digits (implied to meet) |
| SpO2 Accuracy (Toe) | Not explicitly stated for predicate | ±3% (Arms) on the toe |
| Electrical Safety | IEC 60601-1 | Pass |
| Temperature and Humidity | IEC 60601-1, IEC 60601-1-11 | Pass |
| Cleaning | IEC 60601-1 | Pass |
| Electromagnetic Immunity | IEC 60601-1-2 | Pass |
| Bluetooth Certification | Not explicitly stated for predicate | FCC wireless certification Grant (Pass) |
| Performance | ISO 80601-2-61, IEC 60601-1-6 | Pass |
| Ingress Protection | ISO 80601-2-61, IEC 60601-1-11 | Pass |
| Mechanical Durability | ISO 80601-2-61 | Pass |
| Atmospheric Pressure | IEC 60601-1 | Pass |
| Usability | IEC 60601-1-6, IEC 60601-1-11 | Pass |
Study Information
1. A table of acceptance criteria and the reported device performance: See table above.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Clinical Hypoxia Study: 14 healthy, nonsmoking, light-to-dark-skinned subjects. (Prospective study, conducted in an independent research laboratory; no country of origin specified but likely USA given FDA submission).
- Usability/Human Factors Study: 27 healthy competent adult subjects. (Prospective study; no country of origin specified).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Clinical Hypoxia Study: Not explicitly stated as "experts." Ground truth was established by co-oximeters (laboratory instruments, specifically two Radiometer OSM co-oximeters) which are considered the gold standard for measuring arterial oxygen saturation (SaO2) from blood samples. This is an objective measurement rather than an expert consensus.
- Usability/Human Factors Study: No external experts were used to establish ground truth. The study collected user feedback (self-reported satisfaction) and observed performance (ability to perform tasks like placement, assembly, disassembly, and understanding symbols).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Clinical Hypoxia Study: For the SpO2 values at each blood draw, the samples were run on four (4) co-oximeters, and the SpO2 values were paired with the average of two OSM (Radiometer) co-oximeters. This implies a form of consensus/adjudication using these two primary co-oximeters as reference.
- Usability/Human Factors Study: No adjudication method described for this study, as it involved direct observation of user performance and user-completed questionnaires.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not performed. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the primary clinical accuracy study (hypoxia study) was a standalone study. The Model 3230 pulse oximeter's readings were compared directly against the co-oximeter measurements without human interpretation influencing the device's output. The device itself performs the measurement and displays the result. The device is intended for direct readings by users rather than feeding into a larger diagnostic workflow requiring human interpretation of its raw data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Clinical Hypoxia Study: The ground truth for oxygen saturation (SaO2) was established by arterial blood samples measured by laboratory co-oximeters. This is an objective and highly accurate physiological measurement, often considered the gold standard for SaO2.
- Usability/Human Factors Study: The ground truth for usability was based on observed user performance (e.g., successful completion of tasks like device placement, assembly, disassembly, symbol comprehension) and user self-reported satisfaction via questionnaires.
8. The sample size for the training set:
- Not applicable / Not explicitly stated. For a pulse oximeter, "training set" typically refers to the data used to develop the algorithms for SpO2 and pulse rate calculation. This information is usually proprietary to the manufacturer's R&D process and is not typically disclosed in 510(k) summaries for such devices, especially when demonstrating substantial equivalence. The focus is on validation against a clinical test set.
9. How the ground truth for the training set was established:
- Not applicable / Not explicitly stated. As mentioned above, details about the development and "training" (if an algorithm uses machine learning in the modern sense) of the pulse oximeter's core measurement algorithm are not provided. The document focuses on the validation of the device's accuracy against a clinical reference standard.
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GNONIN
2. "510(k) Summary" as required by section 807.92(c)
Submitter:
Phone:
Fax:
Nonin Medical, Inc.
13700 1st Ave. North Plymouth, MN 55441-5443 763-553-9968 763-553-7807
Brodie Pedersen Senior Regulatory Engineer
Date Prepared:
Contact Person:
May 13, 2013
Model 3230
DQA
Pulse Oximeter
Class II, 21 CFR 870.2700
Trade Name:
Classification Name and Number:
Product Code:
Predicate Device(s):
For Starting Career Bearing Boo
Nonin's Model 3230 finger pulse oximeter is substantially equivalent to the Onyx Vantage 9590 cleared by the FDA under K112843 on 4/19/2012, and Model 9560 Onyx II Finger Pulse Oximeter and cleared by the FDA under K081285 on 6/5/2008. As shown in the table below. these devices represent the same technical characteristics as the subject device utilizing the same materials, power source and communication technology. The display of the Model 3230 is a color LCD providing the same information to the user as the predicate LED display.
131021
11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
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GNONIN
| CATEGORY | Identical/Different | 3230 BLE | ONYX® II 9560 | ONYX® VANTAGE 9590 |
|---|---|---|---|---|
| INDICATIONS FOR USE | Similar | The Nonin® Model 3230Finger Pulse Oximeter is asmall, lightweight,portable device indicatedfor use in measuring anddisplaying functionaloxygen saturation ofarterial hemoglobin(%SpO2) and pulse rate ofpatients who are well orpoorly perfused. It isintended for spot-checkingof patients with digitsbetween 0.8 - 2.5 cm (0.3- 1.0 inch) thick. | The Nonin Onyx II Model9560 Finger Pulse Oximeteris a small, lightweight,portable, wireless deviceindicated for use inmeasuring and displayingfunctional oxygensaturation of arterialhemoglobin (%SpO2) andpulse rate of patients whoare well or poorly perfused.It is intended for spot-checking of adult andpediatric patients on fingers(other than the thumb)between 0.3 - 1.0 inch (0.8- 2.5 cm) thick. The device'sintended use environmentsinclude hospitals, clinics,long-term care facilities,skilled nursing facilities,emergency medical servicesand home healthcareservices | The Nonin® Onyx Vantage9590 Finger Pulse Oximeteris a small, lightweight,portable device indicatedfor use in measuring anddisplaying functional oxygensaturation of arterialhemoglobin (%SpO2) andpulse rate of patients whoare well or poorly perfused.It is intended for spot-checking of adult andpediatric patients on digits(fingers, thumb, toes) thatare between 0.3 - 1.0 inch(0.8 - 2.5 cm) thick. Thedevice's intended useenvironments includehospitals, clinics, long-termcare facilities, skillednursing facilities, emergencymedical services, and homehealthcare services. |
| SYSTEM CONFIGURATIONS | ||||
| Parts and Accessories | ||||
| Batteries | Identical for all | LR03 AAA (2) | LR03 AAA (2) | LR03 AAA (2) |
| Operator's instructions | Different | Paper | CD | CD |
| OVERALL SPECIFICATIONS | ||||
| SpO2 Range | Identical for all | 0% to 100% SpO2 | 0% to 100% SpO2 | 0% to 100% SpO2 |
| Pulse Rate Range | Identical for all | 18-321 BPM | 18-321 BPM | 18-321 BPM |
| Accuracy | ||||
| SpO2 | Identical for all | ±2 digits (± 1 Arms) | ±2 digits (± 1 Arms) | ±2 digits (± 1 Arms) |
| Low Perfusion SpO2 | Identical for all | ±2 digits (± 1 Arms) | ±2 digits (± 1 Arms) | ±2 digits (± 1 Arms) |
| Pulse Rate | Identical for all | 20 to 250 BPM ±3 digits | 20 to 250 BPM ±3 digits | 20 to 250 BPM ±3 digits |
| Low Perfusion Pulse Rate | Identical for all | 40 to 240 BPM ±3 digits | 40 to 240 BPM ±3 digits | 40 to 240 BPM ±3 digits |
| Displays | ||||
| CATEGORY | Identical/Different | 3230 BLE | ONYX® II 9560 | ONYX® VANTAGE 9590 |
| 7-Segment 3-Digit Displays | Similar | Multi-pixel 3-Digit Displays | 7-Segment 3-Digit Displays(LEDs) | 7-Segment 3-Digit Displays(LEDs) |
| Pulse Strength Tricolor | Different | LCD, readings or dashesgive two levels of pulsequality indication | Three LED's, Red, Yellowand Green give three levelsof pulse quality indication | Three LED's, Red, Yellowand Green give three levelsof pulse quality indication |
| Connectivity | ||||
| Different | Bluetooth SMART | Saber Bluetooth Module | N/A | |
| Package | Different | Box | Clamshell | Clamshell |
ESTICH J
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Indications for Use:
Model 3230
The Model 3230 Finger Pulse oximeter is a small, lightweight portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot checking of adult and pediatric patients on digits between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick.
Device Description: Model 3230 Bluetooth® Smart Pulse oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LCD display contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate if poor pulse quality that may affect the readings. All associated electronics and the microcontrollers are within the sensor, which is activated by placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.
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GNOMIN
| Testing: | device. | Nonin's Model 3230 Pulse Oximeter is supported by both laboratoryand clinical hypoxia accuracy testing in order to ensure that it hasappropriate performance and functional features to fully comply withrecognized standards and is substantially equivalent to the predicate | |
|---|---|---|---|
| Functional and | |||
| Safety Testing: | Laboratory testing included: software verification, safety testing forelectrical, mechanical, biocompatibility analysis, ingress protection,electromagnetic compatibility, device performance, usability evaluation,wireless Bluetooth certification and mechanical durability have beenperformed to demonstrate equivalency with the predicates. As shownin the table below the device met the relevant requirements of theapplicable recognized standards. | ||
| Test | Reference | Result | |
| Electrical Safety | IEC 60601-1 | Pass | |
| Temperature and Humidity | IEC 60601-1IEC 60601-1-11 | ?ass | |
| Cleaning | IEC 60601-1 | રુકર | |
| Electromagnetic Immunity andEmissions | IEC 60601-1-2 | ? 922 |
| Temperature and Humidity | IEC 60601-1IEC 60601-1-11 | Pass |
|---|---|---|
| Cleaning | IEC 60601-1 | Pass |
| Electromagnetic Immunity andEmissions | IEC 60601-1-2 | Pass |
| Bluetooth Wireless certification | FCC wireless certification Grant | Pass |
| Performance | ISO 80601-2-61IEC 60601-1IEC 60601-1-6 | Pass |
| Ingress Protection | ISO 80601-2-61IEC 60601-1-11 | Pass |
| Mechanical Durability | ISO 80601-2-61 | Pass |
| Atmospheric Pressure | IEC 60601-1 | Pass |
| Usability | IEC 60601-1-6IEC 60601-1-11 | Pass |
Clinical Testing:
HYPOXIA: Clinical testing included induced laboratory hypoxia testing on healthy volunteers and Usability / Human Factors Stucy was performed to get real user feedback from both naïve and experienced pulse oximeter users.
Clinical hypoxia accuracy testing conducted during induced hypoxia studies on 14 healthy, nonsmoking, light-to-dark-skinned subjects in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the device was compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the device is in comparison to
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the co-oximeter samples measured over the SpO2 range of 70-100%. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61 and ISO 9919, Standard Specification for Pulse Oximeters for Accuracy in a non-motion environment demonstrated a specified accuracy of ±2%. There were no reported adverse effects during these investigations.
The purpose of this study was to verify SpO? performance accuracy of the Nonin Medical pulse oximeter system on the finger and thumb in stationary (non-motion) conditions over the range of 70 to 100 percent SaO2. Accuracy of device on the toes was also verified. These aims were achieved by comparing SpO2 measurements with those of arterial blood samples assessed by CO-oximetry. The study was designed in accordance with ISO 80601-2-61 and ISO 9919. The goal, in its entirety, was to show the SpO2 accuracy performance for the devices. It was expected that the Accuracy Root Mean Square (Ams) performance of the above pulse oximetry systems will meet a specification of ±3% for the range of 70 - 100% SaOz.
Methods: Subjects were connected to a breathing circuit, in which the gas flow delivery was adjusted for subject comfort. This gas circuit provided a gas mixture of medical grade oxygen and nitrogen. The program was run in manual mode, in which the gas mixture was changed by the controller. The program was used to induce hypoxia in a stair-stepped manner which allowed each subject to settle at his or her SpOzlevel (e.g. plateau). At each plateau, arterial blood sampling was performed. After drawing a waste sample to clear the arterial line, an arterial sample was drawn. The beginning and end of each draw was noted on the data collection system. This series of waste draw, and arterial draws was repeated multiple times for each plateau. At the end of each plateau, the arterial line was flushed with sterile saline. Subsequently, the program was adjusted to allow the subject to reach a new level of SpOz and the process was repeated. Samples were run on four (4) CO-oximeters. The SpO2 values at each draw were paired with the average of the two OSM (Radiometer) CO-oximeters.
This study enrolled subjects who were provided IRB-approved informed consent as documented on an informed consent form. Subjects needed to be healthy, non-smoking, competent adults, between eighteen and forty-five (18-45) years of age. Good health was evidenced by satisfactory completion of a health assessment form.
Conclusions: The oximeter in a non-motion environment demonstrated a specified accuracy of ±2% over the specified range. The oximeter, in a non-motion environment demonstrated a specified accuracy of ±3% on the toe.
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J.J.
Image /page/5/Picture/1 description: The image shows a stylized text logo. The text appears to read "GINONIN" in a blocky, outlined font. The letters are connected and have a slightly futuristic or industrial aesthetic due to the sharp angles and geometric shapes used in their design.
USABILITY: The testing performed for this Usability / Human Factors Study was to get real user feedback from both naïve and experienced pulse oximeter users.
The primary objective of this study was to collect data to demonstrate the usability of the Model 3230 Oximeter in the intended patient population for simulated home use and identify any potential impediments to use. The usability components tested in this study included effectiveness, symbol comprehension and operator satisfaction. Effectiveness and symbol comprehension were the primary objectives. Operator satisfaction, time to first reading, and time to shut off were secondary objectives.
Effectiveness was assessed by determining the rates of proper placement, proper device assembly, and proper device disassembly.
Methods: Prior to using the device, users were given a Quick Start Guide and Instructions for Use (IFU) that included instructions and diagrams for placement and use of the device. The user was then instructed to perform specific tasks with the device. These tasks simulated home use and include assembly, use, and disassembly of the device After use, the user was asked to complete a questionnaire regarding the various aspects of using the Model 3230 Oximeter, symbol comprehension, and to provide feedback to improve device use or instructions for use.
Usability validation was conducted with 27 subjects. Subjects needed to be healthy competent adults. There were no reported adverse effects during these investigations.
Conclusion: The Model 3230 has been found to be safe and effective for the intended users, uses and use environments.
Conclusion:
Nonin's Model 3230 is substantially equivalent to the On;x Vantage 9590 cleared by the FDA under K112843 on 4/19/2012, and the Model 9560 Onyx II Finger Pulse Oximeter and cleared by the FDA under K081285 on 6/5/2008 both manufactured by Nonin Medical, Inc. The positive results of testing, lead to the conclusion that the revised indications for use and labeling are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2013
Nonin Medical, Incorporated Mr. Brodie C. Pedersen Senior Regulatory Engineer 13700 134 Avenue North PLYMOUTH MN 55441-5443
Re: K131021
Trade/Device Name: Model 3230 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 9, 2013 Received: August 12, 2013
Dear Mr. Pedersen:
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. 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.
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Page 2 - Mr. Pedersen
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
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Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1. Indications for Use Statement
510(K) Number: K131021
Device Name:
Nonin Medical, Inc. Model 3230
Indications for Use: -
Model 3230
The Model 3230 Finger Pulse oximeter is a small, lightweight portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot checking of adult and pediatric patients on digits between 0.3 - 1.0 inch {0.8 - 2.5 cm} thick.
Prescription Use _ · X_ _ _ _ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lester W. Schultheis Jr 2013.09.10 15:59:13 -04'00'
Division Sign-Off) · Iivision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K13102
5
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).