510(k) K032971 ยท DQA Oximeter
TIDAL WAVE SP MODEL 710/715 AND 715
| Applicant | Respironics Novametrix, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Aug 26, 2004 |
| Received | Sep 22, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032971
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Philips Healthcare Inc. Sharn TidalGuard SP 710V, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the inte Terminated |
DQA | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. TidalWave SP 710, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive ca Terminated |
DQA | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Japanese TidalWave SP 710, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the int Terminated |
DQA | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Tidal Wave Sp Model 715, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the inten Terminated |
DQA | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Japanese TidalWave SP 715, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the int Terminated |
DQA | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Resp Profile Monitor, 8100 Cosmo+, Refurbished, Respironics/Philips product.
Used to provide spirometric, carbon dioxide and pulse oximetry monitoring during general anesthesia and in the intensive c Terminated |
DQA | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Refurbished Tidal Wave SP 715, Refurbished, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/rec Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.