510(k) K922712 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
| Applicant | Ambu, Inc., Linthicum MD, US |
| Decision | Substantially Equivalent, Jun 19, 1992 |
| Received | Jun 5, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922712
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.