The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora V20 Blood Glucose Monitoring System.
| Device ID | K100406 |
| 510k Number | K100406 |
| Device Name: | FORA V20 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD. WUGU TOWNSHIP Taipei County, TW 24888 |
| Contact | Nicky Pan |
| Correspondent | Nicky Pan TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD. WUGU TOWNSHIP Taipei County, TW 24888 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-05-11 |
| Summary: | summary |