510(k) K963327 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
| Applicant | Novametrix Medical Systems, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Nov 20, 1996 |
| Received | Aug 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963327
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Philips Healthcare Inc. Tidal wave, Model 610, 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 intensi Terminated |
CCK | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Tidal Wave Model 615, 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 intensiv Terminated |
CCK | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Tidal Wave 610, Refurbished, 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 i Terminated |
CCK | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Tidal Wave - 615, Refurbished, 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 Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.