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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 K190250
Device Name Microscope Navigation
Applicant
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE
Applicant Contact Alexander Schwiersch
Correspondent
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE
Correspondent Contact Hugo Morales
Regulation Number882.4560
Classification Product Code
HAW  
Date Received02/07/2019
Decision Date 09/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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