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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 K252514
Device Name EVAC-MRI
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 Received08/11/2025
Decision Date 11/05/2025
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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