Cleared Traditional

K843422 - OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR
(FDA 510(k) Clearance)

K843422 · Ohmeda Medical · Anesthesiology

Oct 1984

Decision

53d

Days

Class 1

Risk

K843422 is an FDA 510(k) clearance for the OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR, a Absorber, Carbon-dioxide (Class I — General Controls, product code BSF), submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on October 23, 1984, 53 days after receiving the submission on August 31, 1984. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5310.

Submission Details

510(k) Number	K843422 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 1984
Decision Date	October 23, 1984
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—