510(k) K042682 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
| Applicant | Ambu, Inc., Linthicum MD, US |
| Decision | Substantially Equivalent, Nov 15, 2004 |
| Received | Sep 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042682
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.