← Product Code [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA) · K043359 # 4100 PATIENT OXIMETER MODULE (K043359) _Nonin Medical, Inc. · DQA · Jan 7, 2005 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K043359 ## Device Facts - **Applicant:** Nonin Medical, Inc. - **Product Code:** [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA.md) - **Decision Date:** Jan 7, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2700 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The Nonin® Bluetooth® - enabled Model 4100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible Bluetooth - enabled device. ## Device Story Wrist-worn pulse oximeter module; measures SpO2, pulse rate, and plethysmographic data. Device utilizes Bluetooth wireless technology to transmit data to compatible external devices. Powered by two AA batteries. Used in clinical or home settings to monitor patient oxygenation status. Healthcare providers or patients view transmitted data on paired Bluetooth-enabled devices to assist in clinical decision-making regarding patient respiratory or cardiovascular status. ## Clinical Evidence The device underwent both bench and clinical testing to demonstrate functional equivalence to the predicate device. No specific performance metrics (e.g., sensitivity, specificity) were provided in the summary document. ## Technological Characteristics Wrist-worn pulse oximeter; Class II Bluetooth radio (approx. 30-foot range); powered by two AA batteries (approx. 120-hour continuous use). Measures SpO2, pulse rate, and plethysmographic data via optical sensing. ## Regulatory 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. ## Predicate Devices - Avant® Model 4000 Pulse Oximetry System ([K041156](/device/K041156.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K043359 JAN - 7 2005 # SECTION 2. SUMMARY AND CERTIFICATION #### 510(k) Summary A. | Submitter: | Nonin Medical, Inc. | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | John R. Dalpee
Director of Regulatory Affairs
Nonin Medical, Inc.
2605 Fernbrook Lane N.
Plymouth, MN 55447-4755 | | Date Prepared: | December 6, 2004 | | Trade Name: | Model 4100 Patient Oximeter Module | | Classification Name:
and Number: | Class II, 21 CFR 870.2700 | | Product Code: | 74 DQA | | Predicate Device(s): | Nonin's Model 4100 Patient Oximeter Module is
substantially equivalent to the Avant® Model 4000 Pulse
Oximetry System manufactured by Nonin Medical, Inc.
that was cleared by the FDA under K041156 on 6/09/04. | | Device Description: | Nonin's Model 4100 Bluetooth® - enabled wrist-worn
Patient Oximeter Module measures and transmits SpO2,
pulse rate, and plethysmographic data to a compatible
Bluetooth - enabled device. The patient module includes a
class II Bluetooth radio with a range of approximately 30
feet (spherical range).

The 4100 Patient Oximeter Module is powered with two
AA batteries, which last for approximately 120 hours when
used continuously. | | Intended Use: | The Nonin® Bluetooth® - enabled Model 4100 Patient
Oximeter Module is indicated for use in measuring and
transmitting functional oxygen saturation of arterial
hemoglobin (SpO2), pulse rate, and plethysmographic data
to a compatible Bluetooth - enabled device. | | Functional and
Safety Testing: | Nonin's Model 4100 Patient Oximeter Module has
successfully undergone both bench and clinical testing in
order to demonstrate that it has appropriate functional
features and is substantially equivalent to the predicate
device. | | Conclusion: | Nonin's Model 4100 Patient Oximeter Module is
substantially equivalent to the Avant® Model 4000 Pulse
Oximetry System manufactured by Nonin Medical, Inc.
and cleared by the FDA under K041156 on 6/09/04. | {1}------------------------------------------------ and the comments of the comments of the comments of and the comments of the comments of : : : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN - 7 2005 Mr. John R. Dalpee Director of Regulatory Affairs Nonin Medical, Incorporated 2605 Fernbrook Lane North Plymouth, Minnesota 55447-4755 Re: K043359 Trade/Device Name: Model 4100 Patient Oximeter Module Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 6, 2004 Received: December 17, 2004 Dear Mr. Dalpee: 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. {3}------------------------------------------------ Page 2 - Mr. Dalpee 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 (301) 594-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Sutte Michael ms. Chiu Lin, Ph.D. for DR. LIN Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use Statement くなってい 510(K) Number: ## K 04335 Device Name: Nonin Medical, Inc. Model 4100 Patient Oximeter Module ### Indications for Use: The Nonin Bluetooth® - enabled Model 4100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible Bluetooth - enabled device. Sia. G. Semilla (Division Sign Off) Division of Anesthesiology, General Hospital Michael for hesiology, General Hospital, on Control. Dental Devices 510(k) Number:________________________________________________________________________________________________________________________________________________________________ Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE) Nonin Medical Inc. Model 4100 Traditional 510(K): Premarket Notification --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K043359](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K043359) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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