The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Check Td-3215/dr. T Td-3216 Blood Glucose And Blood Pressure Measurement Systems.
Device ID | K051936 |
510k Number | K051936 |
Device Name: | CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS |
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 | Shu-mei Wu |
Correspondent | Shu-mei Wu 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-18 |
Decision Date | 2005-08-08 |