510(k) K190975
K190975 is an FDA 510(k) premarket notification submitted by Midway Medical, LLC for the device "Plexus SCD110 Sequential Compression Device Sleeve". The FDA issued a decision of Substantially Equivalent on Jul 22, 2019. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 22, 2019
- Date Received
- Apr 15, 2019
- 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)