Looper（型号：ZX-579S）
K号: K202055 · 2021-04-16
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决定日期2021-04-16
产品代码OLP
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Looper (Model: ZX-579S) is the device name listed in this FDA 510(k) record. The listed applicant is Heat IN A Click, LLC. It received FDA 510(k) clearance on 2021-04-16 under 510(k) number K202055. 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 Looper (Model: ZX-579S)?
Looper (Model: ZX-579S) is a medical device that received FDA 510(k) clearance on 2021-04-16. The listed applicant is Heat IN A Click, LLC. The 510(k) number is K202055.
When did Looper (Model: ZX-579S) receive FDA 510(k) clearance?
Looper (Model: ZX-579S) received FDA 510(k) clearance on 2021-04-16, under 510(k) number K202055.
Who is the listed applicant for Looper (Model: ZX-579S)?
The FDA 510(k) record lists Heat IN A Click, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Looper (Model: ZX-579S)?
The FDA product code for Looper (Model: ZX-579S) is OLP.
相关临床试验
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。
列明Heat IN A Click, LLC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。
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 CorporationK242068LED光疗面罩（RT01）Ningbo Dechang Electrical Machinery Made Co.,LtdK243555LED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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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