Cleared Traditional

NEOPOP INFANT RESUSCITATOR WITH FLOW METER

K102649 · Neoforce Group, Inc. · Anesthesiology
Jan 2011
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K102649 is an FDA 510(k) clearance for the NEOPOP INFANT RESUSCITATOR WITH FLOW METER, 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 January 6, 2011, 114 days after receiving the submission on September 14, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K102649 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2010
Decision Date January 06, 2011
Days to Decision 114 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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