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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 K211147
Device Name ALGO 7i
Applicant
Path Medical GmbH
Landsberger Strasse 65
Germering,  DE 82110
Applicant Contact Ing. Johann Oswald
Correspondent
Path Medical GmbH
Landsberger Strasse 65
Germering,  DE 82110
Correspondent Contact Ing. Johann Oswald
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received04/19/2021
Decision Date 10/14/2021
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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