Submission Details
| 510(k) Number | K171765 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 14, 2017 |
| Decision Date | October 11, 2017 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
Nihon Kohden CO2 Monitor
Oct 2017
Decision
119d
Days
Class 2
Risk
About This 510(k) Submission
K171765 is an FDA 510(k) clearance for the Nihon Kohden CO2 Monitor, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on October 11, 2017, 119 days after receiving the submission on June 14, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.
Device Classification
| Product Code | CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.1400 |
Manufacturer
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