FDA 510(k)

Clarius 膀胱 AI

K号: K232257 · 2023-11-13

决定日期2023-11-13

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Clarius Bladder 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 2023-11-13 under 510(k) number K232257. 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 Bladder AI?

Clarius Bladder AI is a medical device that received FDA 510(k) clearance on 2023-11-13. The listed applicant is Clarius Mobile Health Corp.. The 510(k) number is K232257.

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

Clarius Bladder AI received FDA 510(k) clearance on 2023-11-13, under 510(k) number K232257.

Who is the listed applicant for Clarius Bladder 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 Bladder AI?

The FDA product code for Clarius Bladder AI is QIH.

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

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K253593Clarius 射血分数 AI K250226Clarius 正中神经 AI K243853Clarius 前列腺 AI K233955Clarius 骨盆 AI K232704Clarius 超声波扫描仪 K222406Clarius AI

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