Cleared Traditional

OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM

K965041 · Ohmeda Medical · Anesthesiology
Jun 1997
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K965041 is an FDA 510(k) clearance for the OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on June 17, 1997, 182 days after receiving the submission on December 17, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K965041 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 1996
Decision Date June 17, 1997
Days to Decision 182 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5160

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