510(k) K950331 ยท BZD Ventilator, Non-Continuous (Respirator)
PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)
| Applicant | Healthdyne, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Sep 21, 1995 |
| Received | Jan 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950331
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.