WAVi™ Headset And WAVi™ ESoc™ Single Use Electrode Contacts

Electrode, Cutaneous

WAVI, CO

The following data is part of a premarket notification filed by Wavi, Co with the FDA for Wavi™ Headset And Wavi™ Esoc™ Single Use Electrode Contacts.

Pre-market Notification Details

• Device ID: K162460
• 510k Number: K162460
• Device Name: WAVi™ Headset And WAVi™ ESoc™ Single Use Electrode Contacts
• Classification: Electrode, Cutaneous
• Applicant: WAVI, CO 3535 S IRVING ST. Englewood, CO 80110
• Contact: Alexis Veracruz
• Correspondent: David Jones; WAVI, CO 3535 S IRVING ST. Englewood, CO 80110
• Product Code: GXY
• CFR Regulation Number: 882.1320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-02
• Decision Date: 2017-04-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B592WH500	K162460	000
B592WH400	K162460	000
B592WH300	K162460	000
B592WH200	K162460	000
B592WE200	K162460	000
B592WE100	K162460	000