Cosmo Plus with Nico, Model 8200

• • Terminated Z-1535-06 FDA Unclassified (pre-2012) ·initiated 11 Aug 2006 ·on shared 510(k) K982499

  Audible alarm may not sound during an alert condition

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K982499 ↗

FDA Product Code

BZC

Device Class

Class II

Regulation

21 CFR Part 868.1880

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. →