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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K843815
Device Name EVOMATIC 8000/4000
Applicant
Dantec Electronics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dantec Electronics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.1870
Classification Product Code
GWF  
Date Received09/28/1984
Decision Date 05/31/1985
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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