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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K222101
Device Name Prism
Applicant
GrayMatters Health Ltd.
82 Ha’ Atzmaut Street
Haifa,  IL
Applicant Contact Adar Shani
Correspondent
RQM+
2251 San Diego Ave, Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number882.5050
Classification Product Code
HCC  
Date Received07/18/2022
Decision Date 03/17/2023
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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