The following data is part of a premarket notification filed by Fim Medical with the FDA for Tabataba Cotester.
| Device ID | K080278 |
| 510k Number | K080278 |
| Device Name: | TABATABA COTESTER |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | FIM MEDICAL PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm FIM MEDICAL PO BOX 7007 Deerfield, IL 60015 |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-04 |
| Decision Date | 2008-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760253450263 | K080278 | 000 |