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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K212164
Device Name Mapping Suction Probe
Applicant
Inomed Medizintechnik GmbH
Im Hausgruen 29
Emmendingen,  DE 79312
Applicant Contact Alexander Maier
Correspondent
Inomed Medizintechnik GmbH
Im Hausgruen 29
Emmendingen,  DE 79312
Correspondent Contact Shuofei Cheng
Regulation Number874.1820
Classification Product Code
ETN  
Date Received07/12/2021
Decision Date 11/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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