510(k) K964584 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
AMBU SPUR NEONATE
| Applicant | Ambu, Inc., Linthicum MD, US |
| Decision | Substantially Equivalent, May 15, 1997 |
| Received | Nov 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964584
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.