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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 K792085
Device Name C-ERA-100 COMPUTERIZED ELECTRIC RESPON
Applicant
MICRO-SHEV LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MICRO-SHEV LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received10/17/1979
Decision Date 10/30/1979
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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