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FDA 510(k)

Orion

K-Number: K200529 · 2020-08-12

ApplicantInteracoustics A/S
Decision Date2020-08-12
Product CodeLXV
DecisionSubstantially Equivalent

Device Summary

Orion is a medical device manufactured by Interacoustics A/S. It received FDA 510(k) clearance on 2020-08-12 under approval number K200529. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orion?

Orion is a medical device that received FDA 510(k) clearance on 2020-08-12. It is manufactured by Interacoustics A/S. The 510(k) number is K200529.

When was Orion approved by the FDA?

Orion received FDA 510(k) clearance on 2020-08-12, under approval number K200529.

What company makes Orion?

Orion is manufactured by Interacoustics A/S.

What is the FDA product code for Orion?

The FDA product code for Orion is LXV.

Other Devices by Interacoustics A/S

K163149VisualEyes K162037Eclipse with VEMP K173567Sera K191372Lyra K200534VisualEyes K192652TRV

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Related Devices (Code: LXV)

K173669K-D BalanceKing-Devick Technologies, Inc. K183661ClearEdge Balance SystemQuadrant Biosciences K190735EQ BalanceUpright Science, Inc. K192652TRVInteracoustics A/S K220231GyroStimUltrathera Technologies, Inc.

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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