510(k) K924341 ยท BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)
HAYEK OSCILLATOR(TM)
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jul 21, 1993 |
| Received | Aug 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924341
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.