NEONATAL RESUSCITATOR, SAMSON— 510(k) K761065

Substantially Equivalent

Dem Medical, Inc.

FDA 510(k) clearance K761065 for NEONATAL RESUSCITATOR, SAMSON, Substantially Equivalent on 1977-01-26. Applicant: Dem Medical, Inc..

Clearance details

Applicant: Dem Medical, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1976-11-18
Decision date: 1977-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.