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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K243205
Device Name EVAC
Applicant
Phasor Health, LLC
8944 Kirby Dr.
Houston,  TX  77054
Applicant Contact Ray King
Correspondent
Phasor Health, LLC
8944 Kirby Dr.
Houston,  TX  77054
Correspondent Contact Ray King
Regulation Number882.5550
Classification Product Code
JXG  
Date Received10/01/2024
Decision Date 06/03/2025
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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