510(k) K162891
K162891 is an FDA 510(k) premarket notification submitted by Coapt, LLC for the device "Complete Control System". The FDA issued a decision of Substantially Equivalent on April 14, 2017. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Coapt, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2017
- Date Received
- October 17, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type