FDA 510(k)

臉心生命指標軟體開發工具包（FH生命指標SDK-RR）

K 號：K243966 · 2025-04-09

決定日期2025-04-09

產品代碼BZQ

諮詢委員會AN

決定相當於

器材摘要

FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) is the device name listed in this FDA 510(k) record. The listed applicant is Faceheart Corp.. It received FDA 510(k) clearance on 2025-04-09 under 510(k) number K243966. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)?

FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) is a medical device that received FDA 510(k) clearance on 2025-04-09. The listed applicant is Faceheart Corp.. The 510(k) number is K243966.

When did FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) receive FDA 510(k) clearance?

FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) received FDA 510(k) clearance on 2025-04-09, under 510(k) number K243966.

Who is the listed applicant for FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)?

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

What is the FDA product code for FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)?

The FDA product code for FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) is BZQ.

其他以 Faceheart Corp. 為申請人之記錄

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K223622臉心生命指標軟體開發工具包（FH生命指標SDK）

相關器械（代碼：BZQ）

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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