510(k) K992057 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
| Applicant | Sims Portex, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Sep 13, 1999 |
| Received | Jun 18, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992057
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.