Cleared Traditional

OHMEDA EXCEL 3000 ANESTHESIA SYSTEM

K973896 · Ohmeda Medical · Anesthesiology
Apr 1998
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K973896 is an FDA 510(k) clearance for the OHMEDA EXCEL 3000 ANESTHESIA 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 April 21, 1998, 189 days after receiving the submission on October 14, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K973896 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1997
Decision Date April 21, 1998
Days to Decision 189 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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