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FDA 510(k)

Ligence Heart

K-Number: K253535 · 2026-02-27

ApplicantLigence Uab
Decision Date2026-02-27
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ligence Heart is a medical device manufactured by Ligence Uab. It received FDA 510(k) clearance on 2026-02-27 under approval number K253535. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ligence Heart?

Ligence Heart is a medical device that received FDA 510(k) clearance on 2026-02-27. It is manufactured by Ligence Uab. The 510(k) number is K253535.

When was Ligence Heart approved by the FDA?

Ligence Heart received FDA 510(k) clearance on 2026-02-27, under approval number K253535.

What company makes Ligence Heart?

Ligence Heart is manufactured by Ligence Uab.

What is the FDA product code for Ligence Heart?

The FDA product code for Ligence Heart is QIH.

Other Devices by Ligence Uab

K252105Ligence Heart

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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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