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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source Localization Software For Electroencephalograph Or Magnetoencephalograph
510(k) Number K252565
Device Name PreOp v3
Applicant
Clouds of Care
Kliniekstraat 27a
Ghent,  BE 9050
Applicant Contact Gregor Strobbe
Correspondent
Clouds of Care
Kliniekstraat 27a
Ghent,  BE 9050
Correspondent Contact Gregor Strobbe
Regulation Number882.1400
Classification Product Code
OLX  
Date Received08/14/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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