Olympus Critical Care Monitoring System

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

510(k) Number

K963935 ↗

FDA Product Code

CCC

Device Class

Class II

Regulation

21 CFR Part 868.1150

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Point-Of-Care Blood Gas Monitor System

  Class II

  FDA 510(k) K961790 Active Cleared 9 Apr 1997

• Capno Probe a

  Class II

  FDA 510(k) K984579 Active Cleared 21 Dec 2000

• Capnoprobe Sl, Model 2000

  Class II

  FDA 510(k) K010795 Active Cleared 11 Apr 2001

• Sensicath Point-of-Care Blood Gas Monitoring Syste

  Class II

  FDA 510(k) K931185 Active Cleared 21 Oct 1993

• Point-Of-Care Arterial Blood Gas Monitoring System

  Class II

  FDA 510(k) K951094 Active Cleared 16 Jan 1996

• Sensilase Pad 3000

  Class II

  FDA 510(k) K040654 Active Cleared 4 Jun 2004