Cleared Traditional

GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM

K070247 · Ohmeda Medical · Anesthesiology
Apr 2007
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K070247 is an FDA 510(k) clearance for the GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on April 20, 2007, 85 days after receiving the submission on January 25, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K070247 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2007
Decision Date April 20, 2007
Days to Decision 85 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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