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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 K050788
Device Name EVERLIFE
Applicant
Everlife Medical Instrument Co., Ltd.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Applicant Contact JEN KE-MIN
Correspondent
Everlife Medical Instrument Co., Ltd.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Correspondent Contact JEN KE-MIN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received03/28/2005
Decision Date 05/13/2005
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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