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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 K222450
Device Name LVIS NeuroMatch
Applicant
LVIS Corporation
2600 East Bayshore Rd.
Palo Alto,  CA  94303
Applicant Contact William Antilla
Correspondent
Veranex, Inc.
224 Airport Parkway
Suite 250
San Jose,  CA  95110
Correspondent Contact Zane Liu
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Codes
OLT   OLX   OMA  
Date Received08/15/2022
Decision Date 06/09/2023
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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