510(k) K171765 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Nihon Kohden CO2 Monitor
| Applicant | Nihon Kohden Corporation, Tokyo, JP |
| Decision | Substantially Equivalent, Oct 11, 2017 |
| Received | Jun 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171765
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2024 | Nihon Kohden America Inc Adult Cap-ONE Biteblock REF YG-227T
The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. Open, Classified |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.