FDA 510(k)

SeleneView® 单次使用数字宫腔镜（HC29，HC29-G，HC35，HC35-G，HO35，HO35-G，HO42，HO42-G）

K号: K240978 · 2024-08-16

申请人MacroLux Medical Technology Co., Ltd.

决定日期2024-08-16

产品代码HIH

咨询委员会OB 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

SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) is the device name listed in this FDA 510(k) record. The listed applicant is MacroLux Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K240978. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)?

SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is MacroLux Medical Technology Co., Ltd.. The 510(k) number is K240978.

When did SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) receive FDA 510(k) clearance?

SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) received FDA 510(k) clearance on 2024-08-16, under 510(k) number K240978.

Who is the listed applicant for SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)?

FDA 510(k)记录将宏鲁克斯医疗科技有限公司列为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)?

The FDA product code for SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) is HIH.

列明MacroLux Medical Technology Co., Ltd.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。

查看所有 7 个设备 →

相关器械（代码：HIH）

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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官方来源

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