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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K172735
Device Name WR19 System
Applicant
Zeto, Inc.
2336 Park Ave.
Santa Clara,  CA  95050
Applicant Contact Aswin Gunasekar
Correspondent
Biologics Consulting Group
1555 King St.,
Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GXY  
Date Received09/11/2017
Decision Date 04/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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