Erchonia Emerald
K号: K192544 · 2020-01-13
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决定日期2020-01-13
产品代码OLI
咨询委员会SU
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决定实质等同
器械摘要
Erchonia Emerald is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2020-01-13 under 510(k) number K192544. 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 Erchonia Emerald?
Erchonia Emerald is a medical device that received FDA 510(k) clearance on 2020-01-13. The listed applicant is Erchonia Corporation. The 510(k) number is K192544.
When did Erchonia Emerald receive FDA 510(k) clearance?
Erchonia Emerald received FDA 510(k) clearance on 2020-01-13, under 510(k) number K192544.
Who is the listed applicant for Erchonia Emerald?
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 Erchonia Emerald?
The FDA product code for Erchonia Emerald is OLI.
相关临床试验
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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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