Cleared Traditional

PERIOPERATIVE DATA MANAGEMENT SYSTEM

K973949 · Draeger Medical, Inc. · Anesthesiology
Feb 1998
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K973949 is an FDA 510(k) clearance for the PERIOPERATIVE DATA MANAGEMENT SYSTEM, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on February 6, 1998, 113 days after receiving the submission on October 16, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K973949 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1997
Decision Date February 06, 1998
Days to Decision 113 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