Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K200568 |
Device Name |
B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System |
Applicant |
B & J Manufacturing Ltd |
Room 701 & 101, Building 24, Block B, Yuanshan Industrial |
Zone, Gongming |
Shenzhen,
CN
518106
|
|
Applicant Contact |
Billy Yu |
Correspondent |
Shenzhen Joyantech Consulting Co., Ltd. |
Room 1713A, 17F, Black A, Time Square, Xili Town |
Shenzhen,
CN
518055
|
|
Correspondent Contact |
Fu Ailing |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 03/04/2020 |
Decision Date | 07/10/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|