510(k) K921002 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED
| Applicant | Rondex Products, Inc., Rockford IL, US |
| Decision | Substantially Equivalent, Oct 6, 1992 |
| Received | Feb 25, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921002
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.