510(k) K904920 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
AMBU MATIC AUTOMATIC RESUSCITATOR
| Applicant | Ambu, Inc., Hanover MD, US |
| Decision | Substantially Equivalent, May 28, 1991 |
| Received | Oct 31, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904920
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.