Cleared Traditional

ANAESTHESIA RECORD KEEPER

K923172 · Datex Division Instrumentarium Corp. · Anesthesiology
Aug 1994
Decision
771d
Days
Class 2
Risk

About This 510(k) Submission

K923172 is an FDA 510(k) clearance for the ANAESTHESIA RECORD KEEPER, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on August 9, 1994, 771 days after receiving the submission on June 29, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K923172 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1992
Decision Date August 09, 1994
Days to Decision 771 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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

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