510(k) K031745 ยท BZD Ventilator, Non-Continuous (Respirator)
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
| Applicant | Sensor Medics Corp., Yorba Linda CA, US |
| Decision | Substantially Equivalent, Feb 13, 2004 |
| Received | Jun 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031745
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.