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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K912775
Device Name SAPPHIRE 4ME EMG/EP SYSTEM
Applicant
Medelec Intl. Corp.
Manor Way
Old Woking, Surrey Gu22 9ju
England,  GB
Applicant Contact J. B HOLLOWAY
Correspondent
Medelec Intl. Corp.
Manor Way
Old Woking, Surrey Gu22 9ju
England,  GB
Correspondent Contact J. B HOLLOWAY
Regulation Number882.1870
Classification Product Code
GWF  
Date Received06/24/1991
Decision Date 11/08/1991
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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