Submission Details
| 510(k) Number | K040875 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 02, 2004 |
| Decision Date | October 15, 2004 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
CAP-ONE, MODEL TG-920P
Oct 2004
Decision
196d
Days
Class 2
Risk
About This 510(k) Submission
K040875 is an FDA 510(k) clearance for the CAP-ONE, MODEL TG-920P, 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 October 15, 2004, 196 days after receiving the submission on April 2, 2004. 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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