Nihon Kohden CO2 Monitor
FDA 510(k) clearance K171765 · decided 2017-10-11
Clearance details
- K-number
- K171765
- Device name
- Nihon Kohden CO2 Monitor
- Applicant
- Nihon Kohden Corporation
- Decision
- Substantially Equivalent
- Date received
- 2017-06-14
- Decision date
- 2017-10-11
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- CCK
- Device class
- 2
- Regulation number
- 868.1400
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and ad recall (Z-0314-2025) | Nihon Kohden America Inc | 2024-11-06 |