Prism— 510(k) K222101

Substantially Equivalent

Graymatters Health , Ltd.

FDA 510(k) clearance K222101 for Prism, Substantially Equivalent on 2023-03-17. Applicant: Graymatters Health , Ltd.. Device class: 2.

Clearance details

Applicant: Graymatters Health , Ltd.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 2022-07-18
Decision date: 2023-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.