510(k) K920379 ยท DQA Oximeter
NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
| Applicant | Novametrix Medical Systems, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Jul 15, 1992 |
| Received | Jan 29, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920379
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Philips Healthcare Inc. Cosmo - Model 7100 SP02 & ETC02 Monitor, Respironics./Philips product.
Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monitoring envi Terminated |
DQA | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Spanish 100-120V Cosmo - 7100 Capnograp, Respironics/Philips products.
Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monitoring envi Terminated |
DQA | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Cosmo Model 7100 SP02 & ETC02 Monitor, Refurbished, Respironics/Philips product.
Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monit Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.