510(k) K991861 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
| Applicant | Sims Portex, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Jan 18, 2000 |
| Received | Jun 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991861
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.