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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K212166
Device Name ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Applicant
Inomed Medizintechnik GmbH
Im Hausgruen 29
Emmendingen,  DE 79312
Applicant Contact Tomasz Moszkowski
Correspondent
Inomed Medizintechnik GmbH
Im Hausgruen 29
Emmendingen,  DE 79312
Correspondent Contact Alexander Maier
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
ETN   GWE   GWJ   GWQ   IKN  
Date Received07/12/2021
Decision Date 01/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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