The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Check Td-3250 Blood Glucose And Blood Pressure Measurement System, Model Td-3250.
Device ID | K061073 |
510k Number | K061073 |
Device Name: | CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
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 | DXN |
Subsequent Product Code | CGA |
Subsequent Product Code | NBW |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-17 |
Decision Date | 2006-06-02 |
Summary: | summary |