510(k) K910019 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON
| Applicant | Novametrix Medical Systems, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Mar 26, 1991 |
| Received | Jan 3, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910019
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V Capnogard 1265, Respironics/Philips product.
Intended to be used for monitoring end tidal CO2 and respiration rate in all critical monitoring environments. Terminated |
CCK | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Spanish Capnogard 1265, Respironics/Philips product.
Intended to be used for monitoring end tidal CO2 and respiration rate in all critical monitoring environments. Terminated |
CCK | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V Capnogard 1265, Refurbished, Respironics/Philips product.
Intended to be used for monitoring end tidal CO2 and respiration rate in all critical monitoring environments in ventilatory support Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.