510(k) K030886 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
NICO WITH MARS, MODEL 7300
| Applicant | Respironics Novametrix, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Oct 7, 2003 |
| Received | Mar 21, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030886
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Philips Healthcare Inc. NICO2, Model 7600 Respironics/Philips Product.
Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation. Terminated |
CCK | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V NICO, 7300 Cardio Mgt system, Respironics/Philips product.
Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation Terminated |
CCK | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. French 100-120V NICO 7300, Respironics/Philips product.
Intended use is: cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during gene Terminated |
CCK | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Spanish 100-120V NICO 7300, Respironics/Philips product.
Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during gene Terminated |
CCK | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. NIC02 Model 7600 Demo Unit, Respironics/Philips product.
Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during gene Terminated |
CCK | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. NIC02 Model 7600 Refurbished, Respironics/Philips product.
Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during ge Terminated |
CCK | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. 100-200V NICO, 7300 Cardio Mgt System, Refurbished, Respironics/Philips product.
The intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechan Terminated |
CCK | None listed |
| Sep 29, 2006 | Respironics Novametrix, LLC. NICO Model 7300
Cardiopulmonary Management System Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.