Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K120634 |
Device Name |
U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM |
Applicant |
TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD |
WUGU DISTRICT |
NEW TAIPEI CITY,
TW
24888
|
|
Applicant Contact |
PINJUNG CHEN |
Correspondent |
TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD |
WUGU DISTRICT |
NEW TAIPEI CITY,
TW
24888
|
|
Correspondent Contact |
PINJUNG CHEN |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 03/01/2012 |
Decision Date | 07/03/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|