Cleared Traditional

Prism

K222101 · Graymatters Health , Ltd. · Neurology
Mar 2023
Decision
242d
Days
Class 2
Risk

About This 510(k) Submission

K222101 is an FDA 510(k) clearance for the Prism, a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Graymatters Health , Ltd. (Haifa, IL). The FDA issued a Cleared decision on March 17, 2023, 242 days after receiving the submission on July 18, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K222101 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2022
Decision Date March 17, 2023
Days to Decision 242 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCC — Device, Biofeedback
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050