免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6

K号: K190663 · 2019-06-17

申请人PAJUNK GmbH Medizintechnologie
决定日期2019-06-17
产品代码BSN
咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同

器械摘要

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2019-06-17 under 510(k) number K190663. The device is classified under product code BSN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6?

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 is a medical device that received FDA 510(k) clearance on 2019-06-17. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K190663.

When did Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 receive FDA 510(k) clearance?

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 received FDA 510(k) clearance on 2019-06-17, under 510(k) number K190663.

Who is the listed applicant for Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6?

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

What is the FDA product code for Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6?

The FDA product code for Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 is BSN.

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PAJUNK GmbH Medizintechnologie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。

K243690SonoMSKK243682SonoPlex STIM；SonoPlex IIK250774SPROTTE® 标准型 (LUER/ NRFit®) 腰椎穿刺K243525SonoTAP和SonoTAP IIK241953SPROTTE® 标准型 (LUER/ NRFit®) 麻醉学K241954SonoBlock; SonoBlock II

查看所有 21 个设备 →

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。

↑