510(k) K993278 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
AMBU NEONATE SILICONE RESUSCITATOR
| Applicant | Ambu, Inc., Linthicum MD, US |
| Decision | Substantially Equivalent, May 17, 2000 |
| Received | Sep 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993278
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.