FDA 510(k)

硬脊膜外迷你過濾器 LUER 80369-7，硬脊膜外迷你過濾器 NRFit 80369-6

K 號：K190663 · 2019-06-17

決定日期2019-06-17

產品代碼BSN

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

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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官方來源

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器材摘要

常見問題

相關臨床試驗

其他以 PAJUNK GmbH Medizintechnologie 為申請人之記錄

官方來源