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FDA 510(k)

Horos Mobile

K-Number: K242552 · 2025-04-08

ApplicantIcat Solutions, Ltd.
Decision Date2025-04-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Horos Mobile is a medical device manufactured by Icat Solutions, Ltd.. It received FDA 510(k) clearance on 2025-04-08 under approval number K242552. 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 Horos Mobile?

Horos Mobile is a medical device that received FDA 510(k) clearance on 2025-04-08. It is manufactured by Icat Solutions, Ltd.. The 510(k) number is K242552.

When was Horos Mobile approved by the FDA?

Horos Mobile received FDA 510(k) clearance on 2025-04-08, under approval number K242552.

What company makes Horos Mobile?

Horos Mobile is manufactured by Icat Solutions, Ltd..

What is the FDA product code for Horos Mobile?

The FDA product code for Horos Mobile is LLZ.

Other Devices by Icat Solutions, Ltd.

K232589Horos MD™

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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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