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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K242345
Device Name Delphi Stimulator
Applicant
QuantalX Neuroscience
1 Hatachana St.
Kfar-Saba,  IL 4453001
Applicant Contact Iftach Dolev
Correspondent
ProMedoss, Inc.
6026 Beech Cove Ln.
Charlotte,  NC  28269
Correspondent Contact Bosmat Friedman-Cox
Regulation Number882.1870
Classification Product Code
GWF  
Date Received08/07/2024
Decision Date 11/05/2024
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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