FDA 510(k)

麗信心臟

K 號：K252105 · 2025-09-26

決定日期2025-09-26

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Ligence Heart is the device name listed in this FDA 510(k) record. The listed applicant is Ligence Uab. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K252105. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ligence Heart?

Ligence Heart is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Ligence Uab. The 510(k) number is K252105.

When did Ligence Heart receive FDA 510(k) clearance?

Ligence Heart received FDA 510(k) clearance on 2025-09-26, under 510(k) number K252105.

Who is the listed applicant for Ligence Heart?

The FDA 510(k) record lists Ligence Uab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ligence Heart?

The FDA product code for Ligence Heart is QIH.

其他以 Ligence Uab 為申請人之記錄

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K253535麗信心臟

相關器械（代碼：QIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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