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FDA 510(k)

Prism

K-Number: K222101 · 2023-03-17

ApplicantGraymatters Health , Ltd.
Decision Date2023-03-17
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Prism is a medical device manufactured by Graymatters Health , Ltd.. It received FDA 510(k) clearance on 2023-03-17 under approval 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. It is manufactured by Graymatters Health , Ltd.. The 510(k) number is K222101.

When was Prism approved by the FDA?

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

What company makes Prism?

Prism is manufactured by Graymatters Health , Ltd..

What is the FDA product code for Prism?

The FDA product code for Prism is HCC.

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Official Source

View on FDA Database →

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

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