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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
510(k) Number K894515
Device Name LISS CRANIAL STIMULATOR MODEL SBL201-M
Applicant
Medical Consultants Intl. , Ltd.
59 Oxford Pl.
Glen Rock,  NJ  07452
Applicant Contact SAUL LISS
Correspondent
Medical Consultants Intl. , Ltd.
59 Oxford Pl.
Glen Rock,  NJ  07452
Correspondent Contact SAUL LISS
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received07/19/1989
Decision Date 05/03/1990
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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