Skip to content

Neonatal Resuscitator, Samson

by Dem Medical, Inc. 510(k)

Active United States

510(k) K761065

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK761065 Date26 Jan 1977ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BTM
Device Class
Class II
Regulation
21 CFR Part 868.5915
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent