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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Index-Generating Electroencephalograph Software
510(k) Number K150298
Device Name Entropy Module, E-ENTROPY-01
Applicant
Ge Healthcare Filand OY
Kuortaneenkatu 2
Helsinki,  FI 00510
Applicant Contact JOEL KENT
Correspondent
GE Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Correspondent Contact JOEL KENT
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OMC   ORT  
Date Received02/06/2015
Decision Date 11/12/2015
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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