510(k) K903745 ยท BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)
THE HAYEK OSCILLATOR
| Applicant | Flexco Medical Instruments, Zurich, Switzerland, CH |
| Decision | Substantially Equivalent, Nov 9, 1990 |
| Received | Aug 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903745
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.