Cleared Traditional

RESUSCI FLOW; RESUSCI FLOW 104

K102542 · Atom Medical Corporation · Anesthesiology
Apr 2011
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K102542 is an FDA 510(k) clearance for the RESUSCI FLOW; RESUSCI FLOW 104, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Atom Medical Corporation (Bonita Springs, US). The FDA issued a Cleared decision on April 6, 2011, 215 days after receiving the submission on September 3, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K102542 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2010
Decision Date April 06, 2011
Days to Decision 215 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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