FDA 510(k)

3 系列光疗仪

K号: K153749 · 2016-06-30

决定日期2016-06-30

产品代码FTC

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决定实质等同

器械摘要

3 Series Phototherapy Unit is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Company. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K153749. 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 3 Series Phototherapy Unit?

3 Series Phototherapy Unit is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Daavlin Distributing Company. The 510(k) number is K153749.

When did 3 Series Phototherapy Unit receive FDA 510(k) clearance?

3 Series Phototherapy Unit received FDA 510(k) clearance on 2016-06-30, under 510(k) number K153749.

Who is the listed applicant for 3 Series Phototherapy Unit?

The FDA 510(k) record lists Daavlin Distributing Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3 Series Phototherapy Unit?

The FDA product code for 3 Series Phototherapy Unit is FTC.

列明Daavlin Distributing Company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。

K182215ClearLink 控制性光疗设备

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, LLC K250425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

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