Cleared Traditional

K841274 - BAG-TO-VENTILATOR SELECTOR VALVE
(FDA 510(k) Clearance)

Apr 1984
Decision
17d
Days
Class 2
Risk

K841274 is an FDA 510(k) clearance for the BAG-TO-VENTILATOR SELECTOR VALVE. This device is classified as a Gas-machine, Anesthesia (Class II - Special Controls, product code BSZ).

Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on April 13, 1984, 17 days after receiving the submission on March 27, 1984.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K841274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1984
Decision Date April 13, 1984
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II - Special Controls
CFR Regulation 21 CFR 868.5160

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