Cleared Traditional

NEOPIP INFANT RESUSCITATOR

K072021 · Neoforce Group, Inc. · Anesthesiology
Sep 2007
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K072021 is an FDA 510(k) clearance for the NEOPIP INFANT RESUSCITATOR, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Neoforce Group, Inc. (Ivyland, US). The FDA issued a Cleared decision on September 12, 2007, 51 days after receiving the submission on July 23, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K072021 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2007
Decision Date September 12, 2007
Days to Decision 51 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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