FDA 510(k)

QT Scanner 2000 型号 A

K号: K190646 · 2019-10-18

决定日期2019-10-18

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

QT Scanner 2000 Model A is the device name listed in this FDA 510(k) record. The listed applicant is Qt Ultrasound, LLC. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K190646. 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 QT Scanner 2000 Model A?

QT Scanner 2000 Model A is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Qt Ultrasound, LLC. The 510(k) number is K190646.

When did QT Scanner 2000 Model A receive FDA 510(k) clearance?

QT Scanner 2000 Model A received FDA 510(k) clearance on 2019-10-18, under 510(k) number K190646.

Who is the listed applicant for QT Scanner 2000 Model A?

The FDA 510(k) record lists Qt Ultrasound, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QT Scanner 2000 Model A?

The FDA product code for QT Scanner 2000 Model A is IYO.

列明Qt Ultrasound, LLC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。

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