FDA 510(k)

Clarius 射血分数 AI

K号: K253593 · 2026-03-02

决定日期2026-03-02

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Clarius Ejection Fraction AI is the device name listed in this FDA 510(k) record. The listed applicant is Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2026-03-02 under 510(k) number K253593. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Clarius Ejection Fraction AI?

Clarius Ejection Fraction AI is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Clarius Mobile Health Corp.. The 510(k) number is K253593.

When did Clarius Ejection Fraction AI receive FDA 510(k) clearance?

Clarius Ejection Fraction AI received FDA 510(k) clearance on 2026-03-02, under 510(k) number K253593.

Who is the listed applicant for Clarius Ejection Fraction AI?

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

What is the FDA product code for Clarius Ejection Fraction AI?

The FDA product code for Clarius Ejection Fraction AI is QIH.

列明Clarius Mobile Health Corp.为申报人的其他记录

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