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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 K210109
Device Name visor2 system
Applicant
Eemagine Medical Imaging Solutions GmbH
Gubenerstr. 47, Fabrik D-10243
Berlin,  DE
Applicant Contact Maarten Van De Velde
Correspondent
Quality & Regulatory Associates, LLC
800 Levanger Lane
Stoughton,  WI  53589
Correspondent Contact Gary J Syring
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Codes
GWF   IKN   OBP  
Date Received01/19/2021
Decision Date 04/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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