FDA 510(k)

VISULAS combi

K号: K233911 · 2024-09-06

决定日期2024-09-06

产品代码HQF

咨询委员会OP 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

VISULAS combi 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 2024-09-06 under 510(k) number K233911. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VISULAS combi?

VISULAS combi is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K233911.

When did VISULAS combi receive FDA 510(k) clearance?

VISULAS combi received FDA 510(k) clearance on 2024-09-06, under 510(k) number K233911.

Who is the listed applicant for VISULAS combi?

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 VISULAS combi?

The FDA product code for VISULAS combi is HQF.

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）K240215BLUE 400; BLUE 400 S K233421RESCAN 700 K232944CALLISTO eye K232159QEVO 系统

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官方来源

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