FDA 510(k)

ClearLink 控制性光疗设备

K号: K182215 · 2018-10-29

决定日期2018-10-29

产品代码FTC

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决定实质等同

器械摘要

ClearLink Controlled Phototherapy Equipment 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 2018-10-29 under 510(k) number K182215. 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 ClearLink Controlled Phototherapy Equipment?

ClearLink Controlled Phototherapy Equipment is a medical device that received FDA 510(k) clearance on 2018-10-29. The listed applicant is Daavlin Distributing Company. The 510(k) number is K182215.

When did ClearLink Controlled Phototherapy Equipment receive FDA 510(k) clearance?

ClearLink Controlled Phototherapy Equipment received FDA 510(k) clearance on 2018-10-29, under 510(k) number K182215.

Who is the listed applicant for ClearLink Controlled Phototherapy Equipment?

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 ClearLink Controlled Phototherapy Equipment?

The FDA product code for ClearLink Controlled Phototherapy Equipment 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。

K1537493 系列光疗仪

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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