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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K062580
Device Name GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
Applicant
Ge Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Applicant Contact JOEL KENT
Correspondent
Ge Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Correspondent Contact JOEL KENT
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/31/2006
Decision Date 12/21/2007
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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