10PL
K号: K220794 · 2022-11-10
广告
决定日期2022-11-10
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
10PL is the device name listed in this FDA 510(k) record. The listed applicant is Tentech Co. , Ltd.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K220794. 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 10PL?
10PL is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Tentech Co. , Ltd.. The 510(k) number is K220794.
When did 10PL receive FDA 510(k) clearance?
10PL received FDA 510(k) clearance on 2022-11-10, under 510(k) number K220794.
Who is the listed applicant for 10PL?
The FDA 510(k) record lists Tentech Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 10PL?
The FDA product code for 10PL is ONF.
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