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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 K223552
Device Name Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
Applicant
Brainlab AG
Olof-Palme-Str.9
Munich,  DE 81829
Applicant Contact Sadwini Suresh
Correspondent
Brainlab AG
Olof-Palme-Str.9
Munich,  DE 81829
Correspondent Contact Sadwini Suresh
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/25/2022
Decision Date 04/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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