510(k) Premarket Notification

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Device Classification Name Stimulator, Cranial Electrotherapy
510(k) Number K903014
Regulation Number 882.5800
Device Name ALPHA-STIM CS
Applicant ELECTROMEDICAL PRODUCTS, INC.
Contact Daniel Kirsch
Classification Product Code JXK
Date Received 07/10/1990
Decision Date 05/12/1992
Classification Advisory Committee

 

Neurology
Review Advisory Committee Neurology
Statement/Summary/Purged Status Purged, no summary or statement
Type Traditional
Reviewed by Third Party No