FDA 510(k)

DemarkQ WOW, DemarkQ POP

K号: K203214 · 2021-07-22

决定日期2021-07-22

产品代码OLP

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决定实质等同

器械摘要

DemarkQ WOW, DemarkQ POP is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical CO , Ltd.. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K203214. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DemarkQ WOW, DemarkQ POP?

DemarkQ WOW, DemarkQ POP is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Shenzhen Kaiyan Medical CO , Ltd.. The 510(k) number is K203214.

When did DemarkQ WOW, DemarkQ POP receive FDA 510(k) clearance?

DemarkQ WOW, DemarkQ POP received FDA 510(k) clearance on 2021-07-22, under 510(k) number K203214.

Who is the listed applicant for DemarkQ WOW, DemarkQ POP?

The FDA 510(k) record lists Shenzhen Kaiyan Medical CO , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DemarkQ WOW, DemarkQ POP?

The FDA product code for DemarkQ WOW, DemarkQ POP is OLP.

列明Shenzhen Kaiyan Medical 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。

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相关器械（代码：OLP）

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。

K253878LUSTRE GoGlow 高级 LED 贴片（PR8001，PR9001）Shenzhen Kaiyan Medical Equipment Co., Ltd.K251843Erchonia EVRLErchonia Corporation K242068LED光疗面罩（RT01）Ningbo Dechang Electrical Machinery Made Co.,Ltd K243555LED光疗面罩（E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A）Shenzhen Eyco Technology Co., Ltd.K232656BLU TOTALE (型号：ENEOB852)Premier North America, Inc.K230490PMD Clean痤疮清洁，型号：4004-CABLUE-NA，4004-GREY-NA，4004-YELLOW-NA，4004-PSTO-NA，4004-LPUR-NA，4004-CABLUE-NA-INT，4004-GREY-INT，4004-YELLOW-INT，4004-PSTO-INT，4004-LPUR-INTDongguan Hunter Electronic Technology Co., Ltd.

官方来源

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