FDA 510(k)

Sleeved IC

K号: K220667 · 2022-12-08

决定日期2022-12-08

产品代码EZD

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决定实质等同

器械摘要

Sleeved IC is the device name listed in this FDA 510(k) record. The listed applicant is Hollister Incorporated. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K220667. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sleeved IC?

Sleeved IC is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Hollister Incorporated. The 510(k) number is K220667.

When did Sleeved IC receive FDA 510(k) clearance?

Sleeved IC received FDA 510(k) clearance on 2022-12-08, under 510(k) number K220667.

Who is the listed applicant for Sleeved IC?

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

What is the FDA product code for Sleeved IC?

The FDA product code for Sleeved IC is EZD.

列明Hollister Incorporated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：EZD）

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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