510(k) K160318
K160318 is an FDA 510(k) premarket notification submitted by Manamed, Inc. for the device "PlasmaFlow". The FDA issued a decision of Substantially Equivalent on April 1, 2016. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Manamed, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2016
- Date Received
- February 5, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type