510(k) K910947 ยท BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)
NEV-10 NEGATIVE PRESSURE VENTILATOR
| Applicant | Lifecare Services, Inc., Lafayette CO, US |
| Decision | Substantially Equivalent, Jun 3, 1991 |
| Received | Mar 6, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910947
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.