FDA 510(k)

CALLISTO eye

K号: K180858 · 2018-06-27

决定日期2018-06-27

产品代码NFJ

咨询委员会RA

决定实质等同

器械摘要

CALLISTO eye is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2018-06-27 under 510(k) number K180858. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CALLISTO eye?

CALLISTO eye is a medical device that received FDA 510(k) clearance on 2018-06-27. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K180858.

When did CALLISTO eye receive FDA 510(k) clearance?

CALLISTO eye received FDA 510(k) clearance on 2018-06-27, under 510(k) number K180858.

Who is the listed applicant for CALLISTO eye?

FDA 510(k)记录显示卡尔蔡司医疗技术股份公司（Carl Zeiss Meditec, AG）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 CALLISTO eye?

The FDA product code for CALLISTO eye is NFJ.

列明Carl Zeiss Meditec, AG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。

K260694蔡司诊所360 K241174INTRABEAM（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）K233911VISULAS combi K240215BLUE 400; BLUE 400 S K233421RESCAN 700 K232944CALLISTO eye

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官方来源

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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。