510(k) K060146
K060146 is an FDA 510(k) premarket notification submitted by Medical Compression Systems (Dbn) , Ltd. for the device "ACTIVECARE ++ SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 8, 2006. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Medical Compression Systems (Dbn) , Ltd. has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 8, 2006
- Date Received
- Jan 19, 2006
- 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)