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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K223577
Device Name Localite TMS Navigator TS
Applicant
Localite GmbH
Auguststr. 1
Bonn,  DE 53229
Applicant Contact Arno Schmitgen
Correspondent
Localite GmbH
Auguststr. 1
Bonn,  DE 53229
Correspondent Contact Arno Schmitgen
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/30/2022
Decision Date 04/17/2023
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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