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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Galvanic Skin Response Measurement
510(k) Number K003480
Device Name BIOFIND
Applicant
Bio-Scan, Inc.
6 Walden Rd.
Corrales,  NM  87048
Applicant Contact BUTCH SMITH
Correspondent
Bio-Scan, Inc.
6 Walden Rd.
Corrales,  NM  87048
Correspondent Contact BUTCH SMITH
Regulation Number882.1540
Classification Product Code
GZO  
Date Received11/09/2000
Decision Date 05/11/2001
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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