Novametrix Model 816A Transcut. Oxygen

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K813352 ↗

FDA Product Code

KLK

Device Class

Class II

Regulation

21 CFR Part 868.2500

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K924626 Active Cleared 3 Dec 1993

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  FDA 510(k) K800988 Active Cleared 28 May 1980

• TC02 M Oxygen Electrode Contact

  Class II

  FDA 510(k) K792009 Active Cleared 26 Oct 1979

• Model 1010 Physiological Signal Telemetry Monitor

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  FDA 510(k) K873672 Active Cleared 3 Dec 1987

• TC02M Electrode Adhesive Rings

  Class II

  FDA 510(k) K792010 Active Cleared 26 Oct 1979

• Novatracer Recorder

  Class I

  FDA 510(k) K811453 Active Cleared 10 Jul 1981

See all devices from Novametrix Medical Systems, Inc. →

• What is the intended use of the Novametrix Model 816A?

  The Novametrix Model 816A is a cutaneous oxygen monitor designed to provide noninvasive monitoring of transcutaneous oxygen levels specifically for infants who are not currently under gas anesthesia.

• What is the regulatory classification of this device?

  This device is classified as a Class 2 medical device under regulation number 868.2500. It has received FDA 510(k) clearance, which indicates that the device has been found to be substantially equivalent to other legally marketed predicate devices.

• Which medical specialty oversees this device?

  The Novametrix Model 816A is categorized under the Anesthesiology medical specialty, as indicated by its review advisory committee and product code classification.