FDA 510(k)

尼普洛干式完全干酸浓缩剂，用于血液透析

K号: K193155 · 2020-11-25

决定日期2020-11-25

产品代码KPO

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决定实质等同

器械摘要

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Renal Solutions USA, Corp.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K193155. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nipro Dry Complete Dry Acid Concentrate for Hemodialysis?

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Nipro Renal Solutions USA, Corp.. The 510(k) number is K193155.

When did Nipro Dry Complete Dry Acid Concentrate for Hemodialysis receive FDA 510(k) clearance?

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis received FDA 510(k) clearance on 2020-11-25, under 510(k) number K193155.

Who is the listed applicant for Nipro Dry Complete Dry Acid Concentrate for Hemodialysis?

The FDA 510(k) record lists Nipro Renal Solutions USA, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nipro Dry Complete Dry Acid Concentrate for Hemodialysis?

The FDA product code for Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is KPO.

列明Nipro Renal Solutions USA, Corp.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。

K223431Citric Complete 液体柠檬酸浓缩液

相关器械（代码：KPO）

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。

官方来源

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