Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K121355 |
Device Name |
WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
Applicant |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
WEST LAKE ECONOMY & TECHNOLOGY |
ZONE |
HANGZHOU, ZHEJIANG,
CN
310030
|
|
Applicant Contact |
REN YUNHUA |
Correspondent |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
WEST LAKE ECONOMY & TECHNOLOGY |
ZONE |
HANGZHOU, ZHEJIANG,
CN
310030
|
|
Correspondent Contact |
REN YUNHUA |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 05/04/2012 |
Decision Date | 07/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|