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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 K901809
Device Name LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25
Applicant
Lumiscope Co., Inc.
400 Raritan Center Pkwy.
Edison,  NJ  08837
Applicant Contact C MORGENIER
Correspondent
Lumiscope Co., Inc.
400 Raritan Center Pkwy.
Edison,  NJ  08837
Correspondent Contact C MORGENIER
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/20/1990
Decision Date 06/18/1990
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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