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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 K771534
Device Name BIOTRON 18
Applicant
BIOTRONICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOTRONICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received08/10/1977
Decision Date 08/26/1977
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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