WAVi Headset and WAVi eSoc Single Use Electrode Contacts— 510(k) K162460

Substantially Equivalent

Wavi Co.

FDA 510(k) clearance K162460 for WAVi Headset and WAVi eSoc Single Use Electrode Contacts, Substantially Equivalent on 2017-04-28. Applicant: Wavi Co..

Clearance details

Applicant: Wavi Co.
Product code: Code GXY
Advisory panel: Neurology
Date received: 2016-09-02
Decision date: 2017-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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