510(k) K052573 ยท MNR Ventilatory Effort Recorder
STARDUST II
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Dec 13, 2005 |
| Received | Sep 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052573
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2008 | Respironics, Inc. Breathing Frequency Monitor Stardust 2 Domestic model number 1025720. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
MNR | None listed |
| Apr 24, 2008 | Respironics, Inc. Stardust Flexible Y Sensor Probe model number 612054. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
MNR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.