510(k) K883434 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
| Applicant | Ambu, Inc., Hanover MD, US |
| Decision | Substantially Equivalent, Sep 14, 1988 |
| Received | Aug 15, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883434
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.