FDA 510(k)

Kubtec Mozart Supra (XPERT 84) X射线系统

K号: K210955 · 2021-09-20

决定日期2021-09-20

产品代码MWP

咨询委员会RA

决定实质等同

器械摘要

Kubtec Mozart Supra (XPERT 84) Radiography System is the device name listed in this FDA 510(k) record. The listed applicant is Kub Technologies, Inc.. It received FDA 510(k) clearance on 2021-09-20 under 510(k) number K210955. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Kubtec Mozart Supra (XPERT 84) Radiography System?

Kubtec Mozart Supra (XPERT 84) Radiography System is a medical device that received FDA 510(k) clearance on 2021-09-20. The listed applicant is Kub Technologies, Inc.. The 510(k) number is K210955.

When did Kubtec Mozart Supra (XPERT 84) Radiography System receive FDA 510(k) clearance?

Kubtec Mozart Supra (XPERT 84) Radiography System received FDA 510(k) clearance on 2021-09-20, under 510(k) number K210955.

Who is the listed applicant for Kubtec Mozart Supra (XPERT 84) Radiography System?

The FDA 510(k) record lists Kub Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kubtec Mozart Supra (XPERT 84) Radiography System?

The FDA product code for Kubtec Mozart Supra (XPERT 84) Radiography System is MWP.

列明Kub Technologies, Inc.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。

K210956Kubtec Mozart (XPERT42)K210957Kubec Xpert 80 X射线系统 K200756Kubtec Mozart Supra K183624Kubtec Mozart (Xpert42)

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