FDA 510(k)

Filter 针对一次性使用

K号: K233277 · 2024-05-10

申请人Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

决定日期2024-05-10

产品代码FPB

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Filter Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K233277. The device is classified under product code FPB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Filter Needle for Single Use?

Filter Needle for Single Use is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. The 510(k) number is K233277.

When did Filter Needle for Single Use receive FDA 510(k) clearance?

Filter Needle for Single Use received FDA 510(k) clearance on 2024-05-10, under 510(k) number K233277.

Who is the listed applicant for Filter Needle for Single Use?

FDA 510(k)记录显示杭州钱塘龙跃生物技术有限公司为申请人。这本身并不能确立该设备制造商。

What is the FDA product code for Filter Needle for Single Use?

The FDA product code for Filter Needle for Single Use is FPB.

列明Hangzhou Qiantang Longyue Biotechnology 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。

K260933安全无菌皮下注射针（NR-S1816R、NR-S1916R、NR-S1925R、NR-S1938R、NR-S2016R、NR-S2025R、NR-S2038R、NR-S2051R、NR-S2116R、NR-S2125R、NR-S2138R、NR-S2151R、NR-S2216R、NR-S2225R、NR-S2238R、NR-S2251R、NR-S2316R、NR-S2325R、NR-S2338R、NR-S2351R、NR-S2516R、NR-S2525R、NR-S2538R、NR-S2551R、NR-S2516T、NR-S2525T、NR-S2538T、NR-S2551T）K260301药瓶适配器 K233287通风瓶适配器 K233284过滤器式安瓿瓶适配器 K222718药瓶适配器

官方来源

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