Cleared Traditional

K833452 - OHIO GMS ABSORBER
(FDA 510(k) Clearance)

Nov 1983
Decision
67d
Days
Class 1
Risk

K833452 is an FDA 510(k) clearance for the OHIO GMS ABSORBER. This device is classified as a Absorber, Carbon-dioxide (Class I - General Controls, product code BSF).

Submitted by Airco/Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on November 29, 1983, 67 days after receiving the submission on September 23, 1983.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5310.

Submission Details

510(k) Number K833452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1983
Decision Date November 29, 1983
Days to Decision 67 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code BSF — Absorber, Carbon-dioxide
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5310