510(k) K913474 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
RESPIRE DISPOSABLE PULMONARY RESUSCITATOR
| Applicant | Med-Tek Innovations, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Feb 3, 1993 |
| Received | Aug 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913474
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.