Submission Details
| 510(k) Number | K083456 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 2008 |
| Decision Date | March 02, 2009 |
| Days to Decision | 101 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Special
NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
Mar 2009
Decision
101d
Days
Class 2
Risk
About This 510(k) Submission
K083456 is an FDA 510(k) clearance for the NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on March 2, 2009, 101 days after receiving the submission on November 21, 2008. 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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