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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 K131141
Device Name EARPROBE
Applicant
PATH MEDICAL GMBH
LANDSBERGER STR 63
GERMERING, BAVARIA,  DE D-82110
Applicant Contact JOHANN OSWALD
Correspondent
PATH MEDICAL GMBH
LANDSBERGER STR 63
GERMERING, BAVARIA,  DE D-82110
Correspondent Contact JOHANN OSWALD
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received04/23/2013
Decision Date 06/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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