510(k) K053174 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
LOFLO C5 CO2 SENSOR
| Applicant | Respironics Novametrix, LLC, Wallingford CT, US |
| Decision | Substantially Equivalent, Jan 12, 2006 |
| Received | Nov 14, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053174
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Philips Healthcare Inc. C5 LOFLO Evaluation Kit, Respironics/Philips product.
Intended use of the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring. Terminated |
CCK | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Evaluation Kit, LOFLO Engine, Respironics/Philips product.
Intended use of the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring. Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.