510(k) K160180
K160180 is an FDA 510(k) premarket notification submitted by Daesung Maref Co., Ltd. for the device "Intermittent Pneumatic Compression system". The FDA issued a decision of Substantially Equivalent on November 3, 2016. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Daesung Maref Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2016
- Date Received
- January 27, 2016
- Clearance Type
- Special
- 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