510(k) K914196 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
RONDEX MASKS MODELS 9015/9011/901102 MODIFIED
| Applicant | Rondex Products, Inc., Rockford IL, US |
| Decision | Substantially Equivalent, Nov 8, 1991 |
| Received | Sep 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914196
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.