FDA 510(k)

FEELject LDV（低死体积）注射器

K号: K213010 · 2023-05-31

决定日期2023-05-31

产品代码QNQ

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

FEELject LDV (Low dead volume) syringe is the device name listed in this FDA 510(k) record. The listed applicant is Feeltech Co., Ltd.. It received FDA 510(k) clearance on 2023-05-31 under 510(k) number K213010. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FEELject LDV (Low dead volume) syringe?

FEELject LDV (Low dead volume) syringe is a medical device that received FDA 510(k) clearance on 2023-05-31. The listed applicant is Feeltech Co., Ltd.. The 510(k) number is K213010.

When did FEELject LDV (Low dead volume) syringe receive FDA 510(k) clearance?

FEELject LDV (Low dead volume) syringe received FDA 510(k) clearance on 2023-05-31, under 510(k) number K213010.

Who is the listed applicant for FEELject LDV (Low dead volume) syringe?

The FDA 510(k) record lists Feeltech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEELject LDV (Low dead volume) syringe?

The FDA product code for FEELject LDV (Low dead volume) syringe is QNQ.

列明Feeltech 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。

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相关器械（代码：QNQ）

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。

K252814Profoject™ 低死腔注射器 /Profoject™ 结核菌素注射器；Profoject™ 低死腔注射器带针 /Profoject™ 结核菌素注射器带针；Profoject™ 低死腔注射器带永久针 /Profoject™ 结核菌素注射器带永久针；Profoject™ 低死腔安全注射器 /Profoject™ 结核菌素安全注射器CMT Health PTE., Ltd.K250127TSK 注射器Tsk Laboratory, Japan K250138小型0.2mL注射器Prosum Medical Limited K242291SOL-M Luer Lock注射器（无针，低残留空间），SOL-M滑尖注射器（无针，低残留空间），SOL-M Luer Lock注射器（低残留空间，可更换针头），SOL-CARE Luer Lock注射器（低残留空间，带安全针），SOL-M滑尖注射器（低残留空间，可更换针头）Sol-Millennium Medical, Inc.K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.K241190PLPT LDV（低残留体积）LC（Luer-Cone）无菌注射器；PLPT LDV（低残留体积）LL（Luer-Lock）无菌注射器Poonglim Pharmatech, Inc.

官方来源

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