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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automatic Event Detection Software For Full-Montage Electroencephalograph
510(k) Number K241390
Device Name NeuroMatch
Applicant
LVIS Corporation
2600 E. Bayshore Rd.
Palo Alto,  CA  94303
Applicant Contact Sweta Srivastava
Correspondent
MCRA, LLC
803 7th St., NW, 3rd Floor
Washington, Dc,  DC  20001
Correspondent Contact Devjani Saha
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Codes
OLT   OMA  
Date Received05/15/2024
Decision Date 11/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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