FDA 510(k)

Citric Complete 液体柠檬酸浓缩液

K号: K223431 · 2023-08-04

决定日期2023-08-04

产品代码KPO

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Citric Complete Liquid Citric Acid Concentrate 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 2023-08-04 under 510(k) number K223431. 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 Citric Complete Liquid Citric Acid Concentrate?

Citric Complete Liquid Citric Acid Concentrate is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Nipro Renal Solutions USA, Corp.. The 510(k) number is K223431.

When did Citric Complete Liquid Citric Acid Concentrate receive FDA 510(k) clearance?

Citric Complete Liquid Citric Acid Concentrate received FDA 510(k) clearance on 2023-08-04, under 510(k) number K223431.

Who is the listed applicant for Citric Complete Liquid Citric Acid Concentrate?

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 Citric Complete Liquid Citric Acid Concentrate?

The FDA product code for Citric Complete Liquid Citric Acid Concentrate 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。

K193155尼普洛干式完全干酸浓缩剂，用于血液透析

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

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。