The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora G30a Blood Glucose Monitoring System, Model Td-4241.
Device ID | K100732 |
510k Number | K100732 |
Device Name: | FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | TaiDoc Technology Corporation 3F, 5F, NO 127 WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
Contact | Nicky Pan |
Correspondent | Nicky Pan TaiDoc Technology Corporation 3F, 5F, 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 | 2010-03-15 |
Decision Date | 2010-07-09 |
Summary: | summary |