FDA 510(k)

神經保護 NerveGuard NRFit，神經保護 LUER

K 號：K170435 · 2017-07-12

決定日期2017-07-12

產品代碼BSP

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

其他以 PAJUNK GmbH Medizintechnologie 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243690SonoMSK K243682SonoPlex STIM；SonoPlex II K250774SPROTTE® 标準 (LUER/NRFit®) 腰椎穿刺 K243525SonoTAP 及 SonoTAP II K241953SPROTTE®標準（LUER/NRFit®）麻醉學 K241954SonoBlock；SonoBlock II

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相關器械（代碼：BSP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243690SonoMSKPAJUNK GmbH Medizintechnologie K243682SonoPlex STIM；SonoPlex IIPAJUNK GmbH Medizintechnologie K250774SPROTTE® 标準 (LUER/NRFit®) 腰椎穿刺PAJUNK GmbH Medizintechnologie K243525SonoTAP 及 SonoTAP IIPAJUNK GmbH Medizintechnologie K241953SPROTTE®標準（LUER/NRFit®）麻醉學PAJUNK GmbH Medizintechnologie K241954SonoBlock；SonoBlock IIPAJUNK GmbH Medizintechnologie

官方來源

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