FDA 510(k)

SPROTTE® 标准型 (LUER/ NRFit®) 麻醉学

K号: K241953 · 2024-11-22

决定日期2024-11-22

产品代码BSP

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

SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology 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 2024-11-22 under 510(k) number K241953. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology?

SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K241953.

When did SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology receive FDA 510(k) clearance?

SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology received FDA 510(k) clearance on 2024-11-22, under 510(k) number K241953.

Who is the listed applicant for SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology?

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 SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology?

The FDA product code for SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology is BSP.

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。

K243690SonoMSK K243682SonoPlex STIM；SonoPlex II K250774SPROTTE® 标准型 (LUER/ NRFit®) 腰椎穿刺 K243525SonoTAP和SonoTAP II K241954SonoBlock; SonoBlock II K230701Stim2Go

查看所有 21 个设备 →

官方来源

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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。