Cleared Traditional

AS/3 MEMORY MODULE, M0MEM

K945234 · Datex Division Instrumentarium Corp. · Anesthesiology
Jan 1995
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K945234 is an FDA 510(k) clearance for the AS/3 MEMORY MODULE, M0MEM, 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 January 27, 1995, 92 days after receiving the submission on October 27, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K945234 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1994
Decision Date January 27, 1995
Days to Decision 92 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

Similar Devices — BSZ Gas-machine, Anesthesia

All 186
Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)
K251352 · Codonics.Incorporated · Jul 2025
Atlan
K230931 · Dr?gerwerk AG & Co KGaA · Jul 2023
Carestation 750/750c
K213867 · Datex-Ohmeda, Inc. · Mar 2023
A8, A9 Anesthesia System
K201957 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2021
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
K191027 · Maquet Critical Care AB · Mar 2020
A7 Anesthesia System
K171292 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2018