The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Blood Glucose Monitoring System, Model Fora G90/td-4234.
Device ID | K091898 |
510k Number | K091898 |
Device Name: | BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234 |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
Contact | Erica Li |
Correspondent | Erica Li TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-24 |
Decision Date | 2009-09-18 |