FDA 510(k)

Ysio Max

K号: K181279 · 2018-06-13

决定日期2018-06-13

产品代码KPR

咨询委员会RA

决定实质等同

器械摘要

Ysio Max is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K181279. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ysio Max?

Ysio Max is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K181279.

When did Ysio Max receive FDA 510(k) clearance?

Ysio Max received FDA 510(k) clearance on 2018-06-13, under 510(k) number K181279.

Who is the listed applicant for Ysio Max?

The FDA 510(k) record lists Siemens Medi Cal Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ysio Max?

The FDA product code for Ysio Max is KPR.

列明Siemens Medi Cal Solutions, 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。

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官方来源

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器械摘要

常见问题

列明Siemens Medi Cal Solutions, Inc.为申报人的其他记录

相关器械（代码：KPR）

官方来源