510(k) K924215 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR
| Applicant | Ambu, Inc., Linthicum MD, US |
| Decision | Substantially Equivalent, Sep 16, 1992 |
| Received | Aug 4, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924215
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.