FDA 510(k)

DAEHAN粘性表面电极

K号: K180247 · 2018-11-01

决定日期2018-11-01

产品代码GXY

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决定实质等同

器械摘要

DAEHAN Adhesive Surface Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Daehan Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K180247. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DAEHAN Adhesive Surface Electrodes?

DAEHAN Adhesive Surface Electrodes is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Daehan Medical Systems Co., Ltd.. The 510(k) number is K180247.

When did DAEHAN Adhesive Surface Electrodes receive FDA 510(k) clearance?

DAEHAN Adhesive Surface Electrodes received FDA 510(k) clearance on 2018-11-01, under 510(k) number K180247.

Who is the listed applicant for DAEHAN Adhesive Surface Electrodes?

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

What is the FDA product code for DAEHAN Adhesive Surface Electrodes?

The FDA product code for DAEHAN Adhesive Surface Electrodes is GXY.

列明Daehan Medical Systems 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。

K180232DAEHAN一次性CUP电极 K161566DMS一次性皮下针电极

相关器械（代码：GXY）

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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