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FDA 510(k)

iSee(roflufocon D,roflufocon E)每日佩戴正畸隐形眼镜

K号: K183200 · 2019-01-09

决定日期2019-01-09
产品代码MUW
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

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is C&E GP Specialist, Inc.. It received FDA 510(k) clearance on 2019-01-09 under 510(k) number K183200. The device is classified under product code MUW. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses?

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses is a medical device that received FDA 510(k) clearance on 2019-01-09. The listed applicant is C&E GP Specialist, Inc.. The 510(k) number is K183200.

When did iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses receive FDA 510(k) clearance?

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses received FDA 510(k) clearance on 2019-01-09, under 510(k) number K183200.

Who is the listed applicant for iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses?

The FDA 510(k) record lists C&E GP Specialist, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses?

The FDA product code for iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses is MUW.

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:MUW)

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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