FDA 510(k)

Diacap Pro Dialyzer

K号: K170574 · 2017-08-11

决定日期2017-08-11

产品代码KDI

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决定实质等同

器械摘要

Diacap Pro Dialyzer is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Avitum AG. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K170574. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Diacap Pro Dialyzer?

Diacap Pro Dialyzer is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is B. Braun Avitum AG. The 510(k) number is K170574.

When did Diacap Pro Dialyzer receive FDA 510(k) clearance?

Diacap Pro Dialyzer received FDA 510(k) clearance on 2017-08-11, under 510(k) number K170574.

Who is the listed applicant for Diacap Pro Dialyzer?

The FDA 510(k) record lists B. Braun Avitum AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diacap Pro Dialyzer?

The FDA product code for Diacap Pro Dialyzer is KDI.

列明B. Braun Avitum AG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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相关器械（代码：KDI）

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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