FDA 510(k)

CWM-930S, FIXER DV9

K号: K233120 · 2024-05-23

决定日期2024-05-23

产品代码GEI

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决定实质等同

器械摘要

CWM-930S, FIXER DV9 is the device name listed in this FDA 510(k) record. The listed applicant is Chungwoo Co., Ltd.. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K233120. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CWM-930S, FIXER DV9?

CWM-930S, FIXER DV9 is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Chungwoo Co., Ltd.. The 510(k) number is K233120.

When did CWM-930S, FIXER DV9 receive FDA 510(k) clearance?

CWM-930S, FIXER DV9 received FDA 510(k) clearance on 2024-05-23, under 510(k) number K233120.

Who is the listed applicant for CWM-930S, FIXER DV9?

The FDA 510(k) record lists Chungwoo Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CWM-930S, FIXER DV9?

The FDA product code for CWM-930S, FIXER DV9 is GEI.

列明Chungwoo Co., Ltd.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。

K222709缩回，CWM-910T，APOLEX Tite

相关器械（代码：GEI）

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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