510(k) K864125 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
CPREVIVER
| Applicant | Augerscope, Inc., Sylmar CA, US |
| Decision | Substantially Equivalent, Feb 26, 1987 |
| Received | Oct 21, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864125
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.