Cleared Traditional

GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM

K070210 · Ohmeda Medical · Anesthesiology
Apr 2007
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K070210 is an FDA 510(k) clearance for the GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on April 20, 2007, 88 days after receiving the submission on January 22, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K070210 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2007
Decision Date April 20, 2007
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTL — Ventilator, Emergency, Powered (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5925

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