Cleared Traditional

LIFEBORNE INFANT RESUSCITATOR

K140707 · International Biomedical · Anesthesiology
May 2014
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K140707 is an FDA 510(k) clearance for the LIFEBORNE INFANT RESUSCITATOR, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on May 28, 2014, 69 days after receiving the submission on March 20, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K140707 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2014
Decision Date May 28, 2014
Days to Decision 69 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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