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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 K260563
Device Name CN-Suite™
Applicant
FIND Surgical Sciences Inc. D/B/A FIND Neuro
1770 Massachusetts Ave.
Suite 806
Cambridge,  MA  02140
Applicant Contact Noam Peled
Correspondent
Healthcare Innovation Catalysts, Inc.
8024 Summer Mill Ct.
Bethesda,  MD  20817
Correspondent Contact Brittany Valdez Nava
Regulation Number882.1400
Classification Product Code
OLX  
Date Received02/19/2026
Decision Date 08/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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