510(k) K032403 ยท NPF Monitor, Apnea, Home Use
SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Oct 27, 2003 |
| Received | Aug 4, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K032403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2008 | Respironics, Inc. Oximeter Patient Cable Masimo 8 ft model number H5870. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
NPF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.