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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Tremor
510(k) Number K782036
Device Name TREMOR MONITOR
Applicant
Columbus Instruments Intl. Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Columbus Instruments Intl. Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.1950
Classification Product Code
GYD  
Date Received12/05/1978
Decision Date 01/23/1979
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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