510(k) K042601 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CAPNOSTAT 5
| Applicant | Respironics Novametrix, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Nov 19, 2004 |
| Received | Sep 24, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042601
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Philips Healthcare Inc. Evaluation Kit, Capnostat 5, Respironics/Philips Product.
Intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system. Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.