The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Td-3224 Blood Glucose Plus Blood Pressure Monitoring System.
Device ID | K081714 |
510k Number | K081714 |
Device Name: | FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM |
Classification | Glucose Oxidase, Glucose |
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 | CGA |
Subsequent Product Code | DXN |
Subsequent 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 | 2008-07-25 |