Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K122482 |
Device Name |
TRANSTEK WRIST BLOOD PRESSURE MONITOR |
Applicant |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
NO. 1 FANGHUA STREET |
HI-TECH ZONE |
CHENGDU,
CN
610041
|
|
Applicant Contact |
LEO WANG |
Correspondent |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
NO. 1 FANGHUA STREET |
HI-TECH ZONE |
CHENGDU,
CN
610041
|
|
Correspondent Contact |
LEO WANG |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 08/14/2012 |
Decision Date | 10/22/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|