FDA 510(k)

Digitex Delivery Device

K号: K173527 · 2018-02-12

决定日期2018-02-12

产品代码PWI

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决定实质等同

器械摘要

Digitex Delivery Device is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2018-02-12 under 510(k) number K173527. The device is classified under product code PWI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Digitex Delivery Device?

Digitex Delivery Device is a medical device that received FDA 510(k) clearance on 2018-02-12. The listed applicant is Coloplast A/S. The 510(k) number is K173527.

When did Digitex Delivery Device receive FDA 510(k) clearance?

Digitex Delivery Device received FDA 510(k) clearance on 2018-02-12, under 510(k) number K173527.

Who is the listed applicant for Digitex Delivery Device?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digitex Delivery Device?

The FDA product code for Digitex Delivery Device is PWI.

列明Coloplast A/S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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