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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Auditory, Evoked Response
510(k) Number K832510
Device Name EVOKED POTENTIALS SYSTEM MK10
Applicant
Amplaid USA, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Amplaid USA, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received07/27/1983
Decision Date 11/25/1983
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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