Criterion II & Iia Oxygen Concentrators

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K871603 ↗

FDA Product Code

CAW

Device Class

Class II

Regulation

21 CFR Part 868.5440

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Adidyne 3000

  Class II

  FDA 510(k) K771707 Active Cleared 26 Sep 1977

• Meck/Miller Ventilation Tube Harness

  Class I

  FDA 510(k) K760993 Active Cleared 9 Dec 1976

• MO8 Oxygen Flowmeter

  Class I

  FDA 510(k) K802311 Active Cleared 23 Oct 1980

• Criterion I

  Class II

  FDA 510(k) K834274 Active Cleared 13 Apr 1984

• Rt-200 Calibration Analyzer

  Class I

  FDA 510(k) K822746 Active Cleared 13 Oct 1982

• Regulator, Oxygen Mechanical

  Class I

  FDA 510(k) K803207 Active Cleared 15 Jan 1981

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