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FDA 510(k)

Horos MD™

K-Number: K232589 · 2024-01-03

ApplicantIcat Solutions, Ltd.
Decision Date2024-01-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Horos MD™ is the device name listed in this FDA 510(k) record. The listed applicant is Icat Solutions, Ltd.. It received FDA 510(k) clearance on 2024-01-03 under 510(k) number K232589. 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 MD™?

Horos MD™ is a medical device that received FDA 510(k) clearance on 2024-01-03. The listed applicant is Icat Solutions, Ltd.. The 510(k) number is K232589.

When did Horos MD™ receive FDA 510(k) clearance?

Horos MD™ received FDA 510(k) clearance on 2024-01-03, under 510(k) number K232589.

Who is the listed applicant for Horos MD™?

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

What is the FDA product code for Horos MD™?

The FDA product code for Horos MD™ is LLZ.

Other records listing Icat Solutions, Ltd. as applicant

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.

K242552Horos Mobile

Related Devices (Code: LLZ)

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.

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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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