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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 K900059
Device Name BIOPOTENTIAL SURFACE ELECTRODE
Applicant
Integral Design, Inc.
52 Burr Rd.
Hingham,  MA  02043
Applicant Contact RICHARD M BEANE
Correspondent
Integral Design, Inc.
52 Burr Rd.
Hingham,  MA  02043
Correspondent Contact RICHARD M BEANE
Regulation Number882.1320
Classification Product Code
GXY  
Date Received01/03/1990
Decision Date 02/22/1990
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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