OPOMAT MANUAL RESUSCITATOR VENTILATOR— 510(k) K912620

Substantially Equivalent

Euro-Am Pharma, Inc.

FDA 510(k) clearance K912620 for OPOMAT MANUAL RESUSCITATOR VENTILATOR, Substantially Equivalent on 1991-12-04. Applicant: Euro-Am Pharma, Inc..

Clearance details

Applicant: Euro-Am Pharma, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1991-06-13
Decision date: 1991-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fanwood, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.