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FDA 510(k)

安全头皮静脉套件，头皮静脉套件，采血针（头皮静脉套件型），采血针（针夹型），安全采血针（头皮静脉套件型），安全采血针（针夹型）

K号: K192681 · 2020-07-28

申请人Jiangsu Kangbao Medical Equipment Co., Ltd.
决定日期2020-07-28
产品代码FPA
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

Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Kangbao Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2020-07-28 under 510(k) number K192681. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)?

Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) is a medical device that received FDA 510(k) clearance on 2020-07-28. The listed applicant is Jiangsu Kangbao Medical Equipment Co., Ltd.. The 510(k) number is K192681.

When did Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) receive FDA 510(k) clearance?

Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) received FDA 510(k) clearance on 2020-07-28, under 510(k) number K192681.

Who is the listed applicant for Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)?

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

What is the FDA product code for Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)?

The FDA product code for Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) is FPA.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Jiangsu Kangbao Medical Equipment 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。

K232881翼型输液器，安全翼型输液器，血液采集套装，带夹血液采集套装，安全血液采集套装，带夹安全血液采集套装K221247无菌一次性使用安全注射器，无菌一次性使用注射器，无菌一次性使用安全针，无菌一次性使用针K211329无菌一次性使用安全针，无菌一次性使用注射器，无菌一次性使用注射器，无菌一次性使用安全针，无菌一次性使用针K182649带Enfit连接器的肠内营养注射器

相关器械（代码：FPA）

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。

K254123Ecomed 一次性给药套装Ecomed Solutions, LLCK261530iiSure 静脉输液器Deka Research and DevelopmentK252543AMSafe 注射器套装（BA-70075，BA-70071-D，BA-70070，BA-70071-P，BA-70072，BA-70072-F，BA-70071-DF，BA-70071-DF-120，FE01，FE04）Amsino International, Inc.K251375PuraCath Firefly 无针连接器 IT (9005)Puracath Medical, Inc.K251257nSet+ 稳定装置 [6426733]; nSet+ 稳定装置带 nSyte 无针连接器 (NFC) [6426731]; nSyte 无针连接器 (NFC) [6426727]Np MedicalK250325BD Alaris 泵输液套装Carefusion (Bd)

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