K961769

Substantially Equivalent

AIR-MEDEX I

Applicant: Robert Gold Assoc.
Product code: FNM
Advisory panel: General Hospital
Date received: 1996-05-08
Decision date: 1996-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Burnswick, NJ, US

Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.