Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K200649 |
Device Name |
Arm-Type Fully Automatic Digital Blood Pressure Monitor |
Applicant |
Joytech Healthcare Co., Ltd |
No.365, Wuzhou Road, Yuhang Economic Development Zone, |
Hangzhou City |
Hangzhou,
CN
311100
|
|
Applicant Contact |
Ren Yunhua |
Correspondent |
Joytech Healthcare Co., Ltd |
No.365, Wuzhou Road, Yuhang Economic Development Zone, |
Hangzhou City |
Hangzhou,
CN
311100
|
|
Correspondent Contact |
Ren Yunhua |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 03/12/2020 |
Decision Date | 08/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|