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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, galvanic skin response measurement
510(k) Number K111308
Device Name ZYTO HAND CRADLE
Applicant
ZYTO TECHNOLOGIES, INC
387 SOUTH 520 WEST
SUITE 200
LINDON,  UT  84042
Applicant Contact VAUGHN R COOK
Correspondent
ZYTO TECHNOLOGIES, INC
387 SOUTH 520 WEST
SUITE 200
LINDON,  UT  84042
Correspondent Contact VAUGHN R COOK
Regulation Number882.1540
Classification Product Code
GZO  
Date Received05/10/2011
Decision Date 08/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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