FDA 510(k)

SPROTTE NRFit, Quincke NRFit 腰椎穿刺針

K 號：K160294 · 2016-10-21

決定日期2016-10-21

產品代碼BSP

諮詢委員會AN

決定相當於

器材摘要

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles 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 2016-10-21 under 510(k) number K160294. 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 SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles?

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K160294.

When did SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles receive FDA 510(k) clearance?

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles received FDA 510(k) clearance on 2016-10-21, under 510(k) number K160294.

Who is the listed applicant for SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles?

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 NRFit, Quincke NRFit Lumbar Puncture needles?

The FDA product code for SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles 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

查看所有 21 項裝置 →

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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