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FDA 510(k)

OrionXR

K-Number: K232189 · 2023-09-14

ApplicantHoth Intelligence, Inc.
Decision Date2023-09-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OrionXR is a medical device manufactured by Hoth Intelligence, Inc.. It received FDA 510(k) clearance on 2023-09-14 under approval number K232189. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OrionXR?

OrionXR is a medical device that received FDA 510(k) clearance on 2023-09-14. It is manufactured by Hoth Intelligence, Inc.. The 510(k) number is K232189.

When was OrionXR approved by the FDA?

OrionXR received FDA 510(k) clearance on 2023-09-14, under approval number K232189.

What company makes OrionXR?

OrionXR is manufactured by Hoth Intelligence, Inc..

What is the FDA product code for OrionXR?

The FDA product code for OrionXR is LLZ.

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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.

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