DUO
K号: K161565 · 2016-09-01
广告
决定日期2016-09-01
产品代码ONF
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
DUO is the device name listed in this FDA 510(k) record. The listed applicant is Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K161565. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DUO?
DUO is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd. The 510(k) number is K161565.
When did DUO receive FDA 510(k) clearance?
DUO received FDA 510(k) clearance on 2016-09-01, under 510(k) number K161565.
Who is the listed applicant for DUO?
The FDA 510(k) record lists Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DUO?
The FDA product code for DUO is ONF.
相关 PubMed 文献
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：ONF）
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。
K261204强脉冲光治疗设备Sanhe LEFIS Electronics Co., Ltd.K251545强脉冲光治疗设备（MMABM-1）Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL治疗设备（MDSQMC-01）Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440强脉冲光治疗系统（LK-PT）Nanjing Bestview Laser S&T 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。
广告