The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Td-3026 Digital Wrist Blood Pressure Monitor, Model Td-3026.
Device ID | K073445 |
510k Number | K073445 |
Device Name: | CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
Contact | Erica Li |
Correspondent | Erica Li TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-07 |
Decision Date | 2008-04-02 |