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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, biofeedback
510(k) Number K894510
Device Name BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH
Applicant
CAPSCAN CORP.
24 BROWNING DR.
OSSINING,  NY  10562
Applicant Contact ADAM CRANE
Correspondent
CAPSCAN CORP.
24 BROWNING DR.
OSSINING,  NY  10562
Correspondent Contact ADAM CRANE
Regulation Number882.5050
Classification Product Code
HCC  
Date Received07/19/1989
Decision Date 01/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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