The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Easy Check Td-4209 Blood Glucose Monitoring System; Clever Check Td-4222, Td-4225, Td-4226 Blood Glucose Monitoring Syst.
Device ID | K062235 |
510k Number | K062235 |
Device Name: | EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, TW 241 |
Contact | Pi-shiou Li |
Correspondent | Pi-shiou Li TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, TW 241 |
Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-02 |
Decision Date | 2006-09-19 |