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FDA 510(k)

NP 医疗 nCompass 扩展套件带稳定底座

K号: K221518 · 2022-11-03

申请人Np Medical
决定日期2022-11-03
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

NP Medical nCompass Extension Set with Stabilizing Base is the device name listed in this FDA 510(k) record. The listed applicant is Np Medical. It received FDA 510(k) clearance on 2022-11-03 under 510(k) number K221518. 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 NP Medical nCompass Extension Set with Stabilizing Base?

NP Medical nCompass Extension Set with Stabilizing Base is a medical device that received FDA 510(k) clearance on 2022-11-03. The listed applicant is Np Medical. The 510(k) number is K221518.

When did NP Medical nCompass Extension Set with Stabilizing Base receive FDA 510(k) clearance?

NP Medical nCompass Extension Set with Stabilizing Base received FDA 510(k) clearance on 2022-11-03, under 510(k) number K221518.

Who is the listed applicant for NP Medical nCompass Extension Set with Stabilizing Base?

The FDA 510(k) record lists Np Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NP Medical nCompass Extension Set with Stabilizing Base?

The FDA product code for NP Medical nCompass Extension Set with Stabilizing Base 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Np Medical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。

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]

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)

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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