The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora D20 Blood Glucose Plus Blood Pressure Monitoring System; Td-3263 Blood Glucose Plus Blood Pressure Monitoring Syste.
| Device ID | K091814 |
| 510k Number | K091814 |
| Device Name: | FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE |
| Classification | Glucose Oxidase, Glucose |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
| Contact | Erica Li |
| Correspondent | Erica Li TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
| Product Code | CGA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-18 |
| Decision Date | 2009-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042010200 | K091814 | 000 |