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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K133012
Device Name SENTIERO
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 Number874.1050
Classification Product Code
EWO  
Subsequent Product Codes
ETY   GWJ  
Date Received09/25/2013
Decision Date 06/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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