FDA 510(k)

Minuteful - 肾脏测试

K号: K210069 · 2022-07-06

决定日期2022-07-06

产品代码JIR

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Minuteful - kidney test is the device name listed in this FDA 510(k) record. The listed applicant is Healthy.Io, Ltd.. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K210069. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Minuteful - kidney test?

Minuteful - kidney test is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is Healthy.Io, Ltd.. The 510(k) number is K210069.

When did Minuteful - kidney test receive FDA 510(k) clearance?

Minuteful - kidney test received FDA 510(k) clearance on 2022-07-06, under 510(k) number K210069.

Who is the listed applicant for Minuteful - kidney test?

The FDA 510(k) record lists Healthy.Io, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Minuteful - kidney test?

The FDA product code for Minuteful - kidney test is JIR.

列明Healthy.Io, 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。

K222921Minuteful-kidney test K182384ACR LAB 尿液分析测试系统 K173327DIP/美国尿液分析测试系统

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。