510(k) K982225 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
| Applicant | Spiracle Technology, Fountain Valley CA, US |
| Decision | Substantially Equivalent, Oct 28, 1998 |
| Received | Jun 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982225
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.