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FDA 510(k)

E-Cath

K号: K152952 · 2016-07-13

决定日期2016-07-13
产品代码BSO
咨询委员会AN
决定Substantially Equivalent

器械摘要

E-Cath is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2016-07-13 under 510(k) number K152952. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the E-Cath?

E-Cath is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K152952.

When did E-Cath receive FDA 510(k) clearance?

E-Cath received FDA 510(k) clearance on 2016-07-13, under 510(k) number K152952.

Who is the listed applicant for E-Cath?

The FDA 510(k) record lists PAJUNK GmbH Medizintechnologie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-Cath?

The FDA product code for E-Cath is BSO.

列明PAJUNK GmbH Medizintechnologie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:BSO)

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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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。

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