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510(k) K222101

Prism by Graymatters Health , Ltd. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2023
Date Received
July 18, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

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