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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 K943101
Device Name GALVANIC SKIN RESPONSE DEVICE
Applicant
Global Ent.
591 W. 1600 N., Suite 214
Orem,  UT  84057
Applicant Contact KATHYRN C COOK
Correspondent
Global Ent.
591 W. 1600 N., Suite 214
Orem,  UT  84057
Correspondent Contact KATHYRN C COOK
Regulation Number882.1540
Classification Product Code
GZO  
Date Received06/29/1994
Decision Date 10/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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