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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transcranial Magnetic Stimulator
510(k) Number K243700
Device Name Apollo TMS Therapy System
Applicant
Mag & More GmbH
Machtlfinger Straße 13
Munich,  DE 81379
Applicant Contact Kerstin Haeringer
Correspondent
Mag & More GmbH
Machtlfinger Straße 13
Munich,  DE 81379
Correspondent Contact Juliane Rieß
Regulation Number882.5805
Classification Product Code
OBP  
Date Received11/29/2024
Decision Date 09/04/2025
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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