510(k) K200568
K200568 is an FDA 510(k) premarket notification submitted by B&J Manufacturing , Ltd. for the device "B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System". The FDA issued a decision of Substantially Equivalent on Jul 10, 2020. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. B&J Manufacturing , Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 10, 2020
- Date Received
- Mar 4, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type
- 510(k)