FDA 510(k)

IOLMaster 700

K号: K173771 · 2018-08-24

决定日期2018-08-24

产品代码HJO

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

IOLMaster 700 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 2018-08-24 under 510(k) number K173771. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IOLMaster 700?

IOLMaster 700 is a medical device that received FDA 510(k) clearance on 2018-08-24. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K173771.

When did IOLMaster 700 receive FDA 510(k) clearance?

IOLMaster 700 received FDA 510(k) clearance on 2018-08-24, under 510(k) number K173771.

Who is the listed applicant for IOLMaster 700?

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 IOLMaster 700?

The FDA product code for IOLMaster 700 is HJO.

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。

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