510(k) K913714 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)
| Applicant | Life Design Systems, Inc., Carrollton TX, US |
| Decision | Substantially Equivalent, Dec 1, 1992 |
| Received | Aug 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913714
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.