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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 K100661
Device Name EARPROBE
Applicant
PATH MEDICAL GMBH
4120 PICADILLY DRIVE
FORT COLLINS,  CO  80526
Applicant Contact KURT RENTEL
Correspondent
PATH MEDICAL GMBH
4120 PICADILLY DRIVE
FORT COLLINS,  CO  80526
Correspondent Contact KURT RENTEL
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received03/08/2010
Decision Date 07/01/2010
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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