U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K112274
Device Name U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM
Applicant
TaiDoc Technology Corporation
3f, 5f, no 127 wugong 2nd rd
wugu district
new taipei city, 

TW

24888

Applicant Contact linda ko
Correspondent
TaiDoc Technology Corporation
3f, 5f, no 127 wugong 2nd rd
wugu district
new taipei city, 

TW

24888

Correspodent Contact linda ko
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 08/08/2011
Decision Date 12/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No