510(k) K923762 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE
| Applicant | Ambu, Inc., Linthicum MD, US |
| Decision | Substantially Equivalent, Feb 5, 1993 |
| Received | Jul 28, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923762
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.