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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K251881
Device Name HippoMind (v1.0)
Applicant
Hippoclinic
1517 Montalto Dr.
Mountain View,  CA  94040
Applicant Contact Zhuhua Cai
Correspondent
Navisure Consulting, LLC
P.O. Box 836032
Richardson,  TX  75083
Correspondent Contact Adam Odeh
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
LLZ   OLY   OMA  
Date Received06/18/2025
Decision Date 12/03/2025
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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