The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fore V10 Blood Glucose Monitoring System, Model Td-4244, Forea V12 Blodo Glucose Monitoring System, Model Td-4247.
| Device ID | K090404 |
| 510k Number | K090404 |
| Device Name: | FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
| Contact | Yuhua Chen |
| Correspondent | Yuhua Chen TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-17 |
| Decision Date | 2009-06-23 |