Novametrix 860 Prota. Transcutaneous Oxygen

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K844079 ↗

FDA Product Code

KLK

Device Class

Class II

Regulation

21 CFR Part 868.2500

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Novametrix Model 510

  Class II

  FDA 510(k) K924626 Active Cleared 3 Dec 1993

• Novametrix Tcomette #809 Trans. Monitor

  Class II

  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

  Class II

  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. →