The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Td-4244 & Td-4245 Blood Glucose Monitoring Systesm.
| Device ID | K081715 |
| 510k Number | K081715 |
| Device Name: | FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Contact | Yuhua Chen |
| Correspondent | Yuhua Chen TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-18 |
| Decision Date | 2008-12-17 |