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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Physiological Signal Based Seizure Monitoring System
510(k) Number K243515
Device Name EpiWatch Monitoring System
Applicant
EpiWatch, Inc.
c/o Johns Hopkins Technology Ventures
1812 Ashland Ave, Suite 110
Baltimore,  MD  21205
Applicant Contact Teresa Prego
Correspondent
Healthcare Innovation Catalysts, Inc.
8024 Summer Mill Court
Bethesda,  MD  20817
Correspondent Contact Brittany Valdez Nava
Regulation Number882.1580
Classification Product Code
POS  
Date Received11/13/2024
Decision Date 03/07/2025
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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