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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, sleep assessment
510(k) Number K862766
Device Name EPISON, ALERTING SYSTEM FOR EPILEPTICS
Applicant
ZYGO INDUSTRIES, INC.
P.O. BOX 1008
PORTLAND,  OR  97207 -1008
Applicant Contact LAWRENCE H WEISS
Correspondent
ZYGO INDUSTRIES, INC.
P.O. BOX 1008
PORTLAND,  OR  97207 -1008
Correspondent Contact LAWRENCE H WEISS
Regulation Number882.5050
Classification Product Code
LEL  
Date Received07/22/1986
Decision Date 03/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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