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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K243243
Device Name Delphi MCS Electrode Cap
Applicant
Quantalx Neuroscience, Ltd.
1 Hatachana St.
Kfar Sava,  IL 4453001
Applicant Contact Hlila Fogel
Correspondent
ProMedoss, Inc.
6026 Beech Cove Ln.
Charlotte,  NC  28269
Correspondent Contact Bosmat Friedman-Cox
Regulation Number882.1320
Classification Product Code
GXY  
Date Received10/11/2024
Decision Date 02/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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