MIE FALCON, DATEX ENGSTROM FLEXIMA II— 510(k) K971030

Name: FDA 510(k) clearance K971030
Creator: U.S. Food and Drug Administration
Published: 1997-11-12

Substantially Equivalent

Medical and Industrial Equipment

FDA 510(k) clearance K971030 for MIE FALCON, DATEX ENGSTROM FLEXIMA II, Substantially Equivalent on 1997-11-12. Applicant: Medical and Industrial Equipment. Device class: 2.

Clearance details

Applicant: Medical and Industrial Equipment
Product code: Code BSZ
Device class: Class 2
Regulation: 21 CFR 868.5160
Advisory panel: Anesthesiology
Date received: 1997-03-20
Decision date: 1997-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ex2 7na Exeter, GB

Download summary PDF View on FDA.gov ↗

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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.