Air Enricher

FDA 510(k) K761213 · Union Carbide Corp.

Substantially Equivalent

510(k) numberK761213

Submission

Device name
Air Enricher
Applicant
Union Carbide Corp.
Mchenry, IL, US
Received
December 7, 1976
Decision date
December 16, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CAW – Generator, Oxygen, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5440
Specialty
Anesthesiology

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Questions and answers

When was Air Enricher cleared by the FDA?

Air Enricher (K761213) received a 510(k) decision of Substantially Equivalent on December 16, 1976, 9 days after the submission was received.

What is the product code of K761213?

The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.