The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Td-3018a Blood Pressure Monitor.
Device ID | K051703 |
510k Number | K051703 |
Device Name: | CLEVER TD-3018A BLOOD PRESSURE MONITOR |
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 |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-24 |
Decision Date | 2005-08-12 |
Summary: | summary |