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FDA 510(k)

裂隙灯,型号:YF-100

K号: K161764 · 2017-02-16

决定日期2017-02-16
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

SLIT LAMP, Model: YF-100 is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Yeasn Science-Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K161764. 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 SLIT LAMP, Model: YF-100?

SLIT LAMP, Model: YF-100 is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Chongqing Yeasn Science-Technology Co., Ltd.. The 510(k) number is K161764.

When did SLIT LAMP, Model: YF-100 receive FDA 510(k) clearance?

SLIT LAMP, Model: YF-100 received FDA 510(k) clearance on 2017-02-16, under 510(k) number K161764.

Who is the listed applicant for SLIT LAMP, Model: YF-100?

The FDA 510(k) record lists Chongqing Yeasn Science-Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLIT LAMP, Model: YF-100?

The FDA product code for SLIT LAMP, Model: YF-100 is HJO.

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。

相关器械(代码:HJO)

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。

官方来源

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