DRAGER GEMINA WALL-MOUNTED WORKPLACE— 510(k) K961886

Substantially Equivalent

Alm Surgical Equipment, Inc.

FDA 510(k) clearance K961886 for DRAGER GEMINA WALL-MOUNTED WORKPLACE, Substantially Equivalent on 1996-07-30. Applicant: Alm Surgical Equipment, Inc..

Clearance details

Applicant: Alm Surgical Equipment, Inc.
Product code: Code FQO
Advisory panel: General, Plastic Surgery
Date received: 1996-05-15
Decision date: 1996-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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.