The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Premium V10 Blood Glucose Monitoring System.
| Device ID | K112275 |
| 510k Number | K112275 |
| Device Name: | FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU DISTRICT New Taipei City, TW 24888 |
| Contact | Linda Ko |
| Correspondent | Linda Ko TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU DISTRICT New Taipei City, TW 24888 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-08 |
| Decision Date | 2011-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042013188 | K112275 | 000 |
| 00816042012716 | K112275 | 000 |
| 00816042011191 | K112275 | 000 |
| 00816042013973 | K112275 | 000 |
| 00816042013195 | K112275 | 000 |