Submission Details
| 510(k) Number | K062115 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 24, 2006 |
| Decision Date | December 27, 2006 |
| Days to Decision | 156 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Special
CARBON DIOXIDE MONITOR, MODEL OLG-2800A
Dec 2006
Decision
156d
Days
Class 2
Risk
About This 510(k) Submission
K062115 is an FDA 510(k) clearance for the CARBON DIOXIDE MONITOR, MODEL OLG-2800A, 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 December 27, 2006, 156 days after receiving the submission on July 24, 2006. 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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