eco-x系列（eco-x，eco-x-s）
K号: K211159 · 2021-12-30
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器械摘要
eco-x Series (eco-x, eco-x-s) is the device name listed in this FDA 510(k) record. The listed applicant is Hdx Will Corp.. It received FDA 510(k) clearance on 2021-12-30 under 510(k) number K211159. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the eco-x Series (eco-x, eco-x-s)?
eco-x Series (eco-x, eco-x-s) is a medical device that received FDA 510(k) clearance on 2021-12-30. The listed applicant is Hdx Will Corp.. The 510(k) number is K211159.
When did eco-x Series (eco-x, eco-x-s) receive FDA 510(k) clearance?
eco-x Series (eco-x, eco-x-s) received FDA 510(k) clearance on 2021-12-30, under 510(k) number K211159.
Who is the listed applicant for eco-x Series (eco-x, eco-x-s)?
The FDA 510(k) record lists Hdx Will Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for eco-x Series (eco-x, eco-x-s)?
The FDA product code for eco-x Series (eco-x, eco-x-s) is OAS.
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Hdx Will Corp.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。
K211114Will3DK212254DENTRIa 系列 (DENTRIa, DENTRI-Ca, DENTRI-Sa)K192700XcamK190357Star-X，口腔X光系统K181297DENTIOIII 系列 (DENTIOIII, DENTIOIII-S)K172168WillCeph医疗设备监管文本翻译：
WillCeph医疗设备符合FDA（美国食品药品监督管理局）510(k)法规要求，PMA（上市前批准）申请中，NCT（临床试验注册号）为XXXXX，PMID（PubMed ID）为XXXXX。设备标识符：XXXXX。请访问以下网址获取更多信息：http://www.example.com/willceph
相关器械（代码：OAS）
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。
K261748牙科锥形束计算机断层扫描（mDX-15P系列）Hefei Meyer Optoelectronic Technology, Inc.K250839牙科 X-ray 系统Changzhou Boen Zhongding Medical Technology Co., Ltd.K260662牙科锥形束CT系统Yofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH 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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