Oxygen Concentrator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844328 ↗

FDA Product Code

CAW

Device Class

Class II

Regulation

21 CFR Part 868.5440

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Disposable Aerosol T

  Class I

  FDA 510(k) K791538 Active Cleared 7 Sep 1979

• Disposable Medication Nebulizer

  Class II

  FDA 510(k) K791536 Active Cleared 7 Sep 1979

• Breathing Circuit Products, Anesthesia

  Class I

  FDA 510(k) K781908 Active Cleared 27 Nov 1978

• Disposable, Manual Pulmonary Resuscitator

  Class II

  FDA 510(k) K873286 Active Cleared 26 Oct 1987

• Disposable Mouthpiece

  Class I

  FDA 510(k) K791537 Active Cleared 7 Sep 1979

• Inflatable Air Splints

  Class I

  FDA 510(k) K853600 Active Cleared 19 Sep 1985

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