FDA 510(k)

Prism

K-Number: K222101 · 2023-03-17

Decision Date2023-03-17

Product CodeHCC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Prism is the device name listed in this FDA 510(k) record. The listed applicant is Graymatters Health , Ltd.. It received FDA 510(k) clearance on 2023-03-17 under 510(k) number K222101. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prism?

Prism is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Graymatters Health , Ltd.. The 510(k) number is K222101.

When did Prism receive FDA 510(k) clearance?

Prism received FDA 510(k) clearance on 2023-03-17, under 510(k) number K222101.

Who is the listed applicant for Prism?

The FDA 510(k) record lists Graymatters Health , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prism?

The FDA product code for Prism is HCC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06854328The Prism Conformity Trial for Post-Traumatic Stress Disorder in AdolescentsRECRUITING

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.