510(k) K943509 ยท BZD Ventilator, Non-Continuous (Respirator)
7300 NASAL CPAP SYSTEM
| Applicant | Healthdyne Technologies, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Aug 5, 1994 |
| Received | Jul 20, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943509
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.