Zerona Z6 非处方药
K号: K162578 · 2016-12-16
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决定日期2016-12-16
产品代码OLI
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
Zerona Z6 OTC is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2016-12-16 under 510(k) number K162578. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Zerona Z6 OTC?
Zerona Z6 OTC is a medical device that received FDA 510(k) clearance on 2016-12-16. The listed applicant is Erchonia Corporation. The 510(k) number is K162578.
When did Zerona Z6 OTC receive FDA 510(k) clearance?
Zerona Z6 OTC received FDA 510(k) clearance on 2016-12-16, under 510(k) number K162578.
Who is the listed applicant for Zerona Z6 OTC?
The FDA 510(k) record lists Erchonia Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zerona Z6 OTC?
The FDA product code for Zerona Z6 OTC is OLI.
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Erchonia Corporation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：OLI）
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。
K260688Sculpt LED腰带（HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C）Shenzhen Kaiyan Medical Equipment Co., Ltd.K260129Lumaflex面板（ZLD-05，ZLD-05A，ZLD-05APro）Shenzhen Kaiyan Medical Equipment Co., Ltd.K243854Contour 光（CL-100）Contour Research, LLCK252574Erchonia CLX (型号 # CFL)Erchonia CorporationK252786LED 光疗床（Pro 450/ GY-680A）Shenzhen Suyzeko Limited.K243811Erchonia Zerona® VZ8Erchonia Corporation
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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