The following data is part of a premarket notification filed by B & J Manufacturing Ltd with the FDA for B&j Mhp800 Deep Vein Thrombosis (dvt) Prevention System.
Device ID | K200568 |
510k Number | K200568 |
Device Name: | B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System |
Classification | Sleeve, Limb, Compressible |
Applicant | B & J Manufacturing Ltd Room 701 & 101, Building 24, Block B, Yuanshan Industrial Zone, Gongming Shenzhen, CN 518106 |
Contact | Billy Yu |
Correspondent | Fu Ailing Shenzhen Joyantech Consulting Co., Ltd. Room 1713A, 17F, Black A, Time Square, Xili Town Shenzhen, CN 518055 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-04 |
Decision Date | 2020-07-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06975298105031 | K200568 | 000 |