The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Carbon Dioxide Monitor, Model Olg-2800a.
| Device ID | K062115 |
| 510k Number | K062115 |
| Device Name: | CARBON DIOXIDE MONITOR, MODEL OLG-2800A |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Serrah Namini |
| Correspondent | Serrah Namini NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2006-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04931921874080 | K062115 | 000 |
| 04931921103814 | K062115 | 000 |
| 00841983102295 | K062115 | 000 |
| 00841983101878 | K062115 | 000 |