DRAGER DVE 4000 SERIES SYSTEM— 510(k) K921297

Name: FDA 510(k) clearance K921297
Creator: U.S. Food and Drug Administration
Published: 1992-11-27

Substantially Equivalent

Alm Surgical Equipment, Inc.

FDA 510(k) clearance K921297 for DRAGER DVE 4000 SERIES SYSTEM, Substantially Equivalent on 1992-11-27. Applicant: Alm Surgical Equipment, Inc.. Device class: 1.

Clearance details

Applicant: Alm Surgical Equipment, Inc.
Product code: Code FQO
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1992-03-17
Decision date: 1992-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FQO

product code FQO

Death: 6
Injury: 145
Malfunction: 685
Total: 836

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.