510(k) K231801
K231801 is an FDA 510(k) premarket notification submitted by Medhealth Medical Limited for the device "MedHealth DVT compression Devices MHH900S/MHH900E". The FDA issued a decision of Substantially Equivalent on Dec 14, 2023. 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
- Dec 14, 2023
- Date Received
- Jun 20, 2023
- 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