Cleared Traditional

DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE

K082092 · Galemed Corp. · Anesthesiology
Oct 2008
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K082092 is an FDA 510(k) clearance for the DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Galemed Corp. (Carlsbad, US). The FDA issued a Cleared decision on October 15, 2008, 83 days after receiving the submission on July 24, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K082092 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2008
Decision Date October 15, 2008
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTM — Ventilator, Emergency, Manual (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5915

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