Cleared Special

Puffin Lite Infant Resuscitation System

K182956 · International Biomedical · Anesthesiology
Jan 2019
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K182956 is an FDA 510(k) clearance for the Puffin Lite Infant Resuscitation System, 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 January 18, 2019, 86 days after receiving the submission on October 24, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K182956 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2018
Decision Date January 18, 2019
Days to Decision 86 days
Submission Type Special
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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