The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Advocate Duo Blood Glucose Plus Blood Pressure Monitoring System, Model Td-3223.
Device ID | K070641 |
510k Number | K070641 |
Device Name: | ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | TaiDoc Technology Corporation 4F, NO. 88, SEC.1, KWANG-FU RD SAN-CHUNG Taipei County, TW 241 |
Contact | Erica Li |
Correspondent | Erica Li TaiDoc Technology Corporation 4F, NO. 88, SEC.1, KWANG-FU RD SAN-CHUNG Taipei County, TW 241 |
Product Code | NBW |
Subsequent Product Code | CGA |
Subsequent Product Code | DXN |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-08 |
Decision Date | 2007-04-09 |