Esteya
K号: K213942 · 2022-01-11
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器械摘要
Esteya is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron B.V.. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K213942. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Esteya?
Esteya is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Nucletron B.V.. The 510(k) number is K213942.
When did Esteya receive FDA 510(k) clearance?
Esteya received FDA 510(k) clearance on 2022-01-11, under 510(k) number K213942.
Who is the listed applicant for Esteya?
FDA 510(k)记录中列出Nucletron B.V.为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for Esteya?
The FDA product code for Esteya is JAD.
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Nucletron B.V.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：JAD）
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。
K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM（700）；以及附件（INTRABEAM SMART Stand，INTRABEAM SMART 球形应用器，INTRABEAM 球形尺寸套装，INTRABEAM 针状应用器）Carl Zeiss Meditec, AGK230611X80 / RADiant / 光电疗法系统（RADiant Aura）Xstrahl, Ltd.K190255Sensus Healthcare TVM 气球应用器Sensus Healthcare, Inc.K182641Sensus IORT 系统Sensus Healthcare, Inc.K173425SRT-100+Sensus Healthcare, Inc.
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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