The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora V12 No-coding Blood Glucose Monitoring System, Model Td-4247.
| Device ID | K090536 |
| 510k Number | K090536 |
| Device Name: | FORA V12 NO-CODING BLOOD 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 248 |
| Contact | Sophie Lin |
| Correspondent | Sophie Lin 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 | 2009-02-27 |
| Decision Date | 2009-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042013270 | K090536 | 000 |
| 00816042012273 | K090536 | 000 |
| 00816042012020 | K090536 | 000 |
| 00816042010972 | K090536 | 000 |
| 00816042010965 | K090536 | 000 |