510(k) K981308 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG
| Applicant | International Respiratory Systems, Inc., Crofton MD, US |
| Decision | Substantially Equivalent, Jul 6, 1998 |
| Received | Apr 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981308
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.