The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora G71a Blood Glucose Monitoring System, Td-4274 Blood Glucose Monitoring System.
Device ID | K093712 |
510k Number | K093712 |
Device Name: | FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM |
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 | Nicky Pan |
Correspondent | Nicky Pan 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 | 2009-12-02 |
Decision Date | 2010-02-19 |
Summary: | summary |