The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora G72 Blodo Glucose Monitoring System/td-4264 Blood Glucose Monitoring System, Model Td-4264.
Device ID | K093005 |
510k Number | K093005 |
Device Name: | FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264 |
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 | Teling Hsu |
Correspondent | Teling Hsu 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 | 2009-09-28 |
Decision Date | 2010-02-05 |
Summary: | summary |