510(k) K984254 ยท BZD Ventilator, Non-Continuous (Respirator)
INFANT FLOW NCPAP MASKS
| Applicant | Sensor Medics Corp., Yorba Linda CA, US |
| Decision | Substantially Equivalent, Feb 24, 1999 |
| Received | Nov 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984254
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.