NerveGuard NRFit, NerveGuard LUER
K号: K170435 · 2017-07-12
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决定日期2017-07-12
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
NerveGuard NRFit, NerveGuard LUER 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 2017-07-12 under 510(k) number K170435. 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 NerveGuard NRFit, NerveGuard LUER?
NerveGuard NRFit, NerveGuard LUER is a medical device that received FDA 510(k) clearance on 2017-07-12. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K170435.
When did NerveGuard NRFit, NerveGuard LUER receive FDA 510(k) clearance?
NerveGuard NRFit, NerveGuard LUER received FDA 510(k) clearance on 2017-07-12, under 510(k) number K170435.
Who is the listed applicant for NerveGuard NRFit, NerveGuard LUER?
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 NerveGuard NRFit, NerveGuard LUER?
The FDA product code for NerveGuard NRFit, NerveGuard LUER is BSP.
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。
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。
相关器械（代码：BSP）
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。
K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM；SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® 标准型 (LUER/ NRFit®) 腰椎穿刺PAJUNK GmbH MedizintechnologieK243525SonoTAP和SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® 标准型 (LUER/ NRFit®) 麻醉学PAJUNK GmbH MedizintechnologieK241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie
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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