510(k) K834250 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
RESCUE MASK
| Applicant | Rondex Products, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 18, 1984 |
| Received | Dec 7, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K834250
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.