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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 K220139
Device Name QScreen
Applicant
Path Medical GmbH
Landsberger Strasse 65
Germering,  DE 82110
Applicant Contact Johann Oswald
Correspondent
Path Medical GmbH
Landsberger Strasse 65
Germering,  DE 82110
Correspondent Contact Johann Oswald
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received01/18/2022
Decision Date 08/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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