DATEX AS/3 TM ANAESTHESIA MONITOR— 510(k) K933285

Name: FDA 510(k) clearance K933285
Creator: U.S. Food and Drug Administration
Published: 1994-11-14

Substantially Equivalent

Datex Division Instrumentarium Corp.

FDA 510(k) clearance K933285 for DATEX AS/3 TM ANAESTHESIA MONITOR, Substantially Equivalent on 1994-11-14. Applicant: Datex Division Instrumentarium Corp.. Device class: 2.

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Code BSZ
Device class: Class 2
Regulation: 21 CFR 868.5160
Advisory panel: Anesthesiology
Date received: 1993-07-06
Decision date: 1994-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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K953175 — AS/3 ESTPR MODULE1997-02-06
K961247 — AS/3 LIGHT MONITOR1996-10-23
K943458 — AS/3 AIRWAY MODULE1995-02-14
K945234 — AS/3 MEMORY MODULE, M0MEM1995-01-27
K933156 — DATEX AS/3 PATIENT MONITOR1994-12-30

Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.