510(k) K910040 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT
| Applicant | Ambu, Inc., Hanover MD, US |
| Decision | Substantially Equivalent, May 28, 1991 |
| Received | Jan 4, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910040
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.