Cleared Abbreviated

NEONATALIE RESUSCITATOR

K132172 · Laerdal Medical A/S · Anesthesiology
Jan 2015
Decision
549d
Days
Class 2
Risk

About This 510(k) Submission

K132172 is an FDA 510(k) clearance for the NEONATALIE RESUSCITATOR, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Laerdal Medical A/S (Stavanger, NO). The FDA issued a Cleared decision on January 15, 2015, 549 days after receiving the submission on July 15, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K132172 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2013
Decision Date January 15, 2015
Days to Decision 549 days
Submission Type Abbreviated
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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