510(k) K974453 ยท BZD Ventilator, Non-Continuous (Respirator)
NASAL INTERFACE MODEL 7910
| Applicant | Healthdyne Technologies, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Aug 4, 1998 |
| Received | Nov 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974453
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.