510(k) K103578 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
| Applicant | Respironics Novametrix, LLC, Wallingford CT, US |
| Decision | Substantially Equivalent, Jun 2, 2011 |
| Received | Dec 6, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103578
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.