Cleared Traditional

OHMEDA INFANT RESUSCITATION SYSTEM

K971243 · Ohmeda Medical · Anesthesiology
Dec 1997
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K971243 is an FDA 510(k) clearance for the OHMEDA INFANT RESUSCITATION SYSTEM, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on December 2, 1997, 243 days after receiving the submission on April 3, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K971243 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1997
Decision Date December 02, 1997
Days to Decision 243 days
Submission Type Traditional
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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