Cleared Traditional

RESUSCITATION UNIT 105

K103317 · Atom Medical Corporation · Anesthesiology
Apr 2011
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K103317 is an FDA 510(k) clearance for the RESUSCITATION UNIT 105, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Atom Medical Corporation (Bonita Springs, US). The FDA issued a Cleared decision on April 20, 2011, 161 days after receiving the submission on November 10, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number K103317 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 2010
Decision Date April 20, 2011
Days to Decision 161 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZR — Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5330

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