Cleared Traditional

K933285 - DATEX AS/3 TM ANAESTHESIA MONITOR
(FDA 510(k) Clearance)

K933285 · Datex Division Instrumentarium Corp. · Anesthesiology
Nov 1994
Decision
496d
Days
Class 2
Risk

K933285 is an FDA 510(k) clearance for the DATEX AS/3 TM ANAESTHESIA MONITOR, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Datex Division Instrumentarium Corp. (Helsinki, FI). The FDA issued a Cleared decision on November 14, 1994, 496 days after receiving the submission on July 6, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K933285 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1993
Decision Date November 14, 1994
Days to Decision 496 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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