FDA 510(k)

膀胱扫描仪，型号名称：M5

K号: K213488 · 2022-07-01

申请人Suzhou Peaksonic Medical Technology Co., Ltd.

决定日期2022-07-01

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

Bladder Scanner, Model Name:M5 is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Peaksonic Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K213488. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bladder Scanner, Model Name:M5?

Bladder Scanner, Model Name:M5 is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Suzhou Peaksonic Medical Technology Co., Ltd.. The 510(k) number is K213488.

When did Bladder Scanner, Model Name:M5 receive FDA 510(k) clearance?

Bladder Scanner, Model Name:M5 received FDA 510(k) clearance on 2022-07-01, under 510(k) number K213488.

Who is the listed applicant for Bladder Scanner, Model Name:M5?

The FDA 510(k) record lists Suzhou Peaksonic Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bladder Scanner, Model Name:M5?

The FDA product code for Bladder Scanner, Model Name:M5 is IYO.

列明Suzhou Peaksonic Medical Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K201316膀胱扫描仪（型号：M3，M3-HD，M4，M4-HD）

官方来源

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