M系列光疗设备
K号: K210881 · 2021-06-22
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决定日期2021-06-22
产品代码FTC
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
M Series Phototherapy Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Co.. It received FDA 510(k) clearance on 2021-06-22 under 510(k) number K210881. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the M Series Phototherapy Equipment?
M Series Phototherapy Equipment is a medical device that received FDA 510(k) clearance on 2021-06-22. The listed applicant is Daavlin Distributing Co.. The 510(k) number is K210881.
When did M Series Phototherapy Equipment receive FDA 510(k) clearance?
M Series Phototherapy Equipment received FDA 510(k) clearance on 2021-06-22, under 510(k) number K210881.
Who is the listed applicant for M Series Phototherapy Equipment?
The FDA 510(k) record lists Daavlin Distributing Co. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for M Series Phototherapy Equipment?
The FDA product code for M Series Phototherapy Equipment is FTC.
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Daavlin Distributing Co.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：FTC）
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。
K254234光疗系统 (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite（RCW-KL1000）Radcliffe Watts, LLCK250425紫外线光疗设备APK Technology Co., Ltd.K244022308nm紫外线光疗系统（UV-K）；308nm紫外线光疗系统（UV-X）；308nm紫外线光疗系统（UV-Y）；308nm紫外线光疗系统（UV-Z）Boston Aesthetics, Inc.K242977308nm准分子光疗设备（CN-308E，KN-4003B3，KN-4003B4，KN-5000C KN-5000D，KN-5000H，KN-5000K）Xuzhou Kernel Medical Equipment Co., Ltd.K242908紫外线光疗设备（A组：SQ308PCHFD，SQ308PCQFD，SQ308PCPFD，SQ308PCNFD，SQ308PCMFD）；紫外线光疗设备（B组：SQ308PHTFF，SQ308PHSFF，SQ308PHRFF，SQ308PHZFG，SQ308PPUFF，SQ308PPVFF，SQ308PPWFG）Shanghai Sigma High-Tech 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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