510(k) K162460
K162460 is an FDA 510(k) premarket notification submitted by Wavi Co. for the device "WAVi Headset and WAVi eSoc Single Use Electrode Contacts". The FDA issued a decision of Substantially Equivalent on April 28, 2017. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Wavi Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2017
- Date Received
- September 2, 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