FDA 510(k)

MiVu™ 食管内窥镜帽

K号: K230056 · 2023-04-25

决定日期2023-04-25

产品代码QIS

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决定实质等同

器械摘要

MiVu™ Esophageal Endo Cap is the device name listed in this FDA 510(k) record. The listed applicant is Diversatek Healthcare. It received FDA 510(k) clearance on 2023-04-25 under 510(k) number K230056. The device is classified under product code QIS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MiVu™ Esophageal Endo Cap?

MiVu™ Esophageal Endo Cap is a medical device that received FDA 510(k) clearance on 2023-04-25. The listed applicant is Diversatek Healthcare. The 510(k) number is K230056.

When did MiVu™ Esophageal Endo Cap receive FDA 510(k) clearance?

MiVu™ Esophageal Endo Cap received FDA 510(k) clearance on 2023-04-25, under 510(k) number K230056.

Who is the listed applicant for MiVu™ Esophageal Endo Cap?

The FDA 510(k) record lists Diversatek Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiVu™ Esophageal Endo Cap?

The FDA product code for MiVu™ Esophageal Endo Cap is QIS.

列明Diversatek Healthcare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。

K222734Diversatek Healthcare PureFlo 灌注系统/水瓶软管 K190208Diversatek Healthcare 高分辨率阻抗测压（HRiM）探头

官方来源

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