FDA 510(k)

SonoBlock；SonoBlock II

K 號：K241954 · 2024-09-11

決定日期2024-09-11

產品代碼BSP

諮詢委員會AN

決定相當於

器材摘要

SonoBlock; SonoBlock II 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 2024-09-11 under 510(k) number K241954. 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 SonoBlock; SonoBlock II?

SonoBlock; SonoBlock II is a medical device that received FDA 510(k) clearance on 2024-09-11. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K241954.

When did SonoBlock; SonoBlock II receive FDA 510(k) clearance?

SonoBlock; SonoBlock II received FDA 510(k) clearance on 2024-09-11, under 510(k) number K241954.

Who is the listed applicant for SonoBlock; SonoBlock II?

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 SonoBlock; SonoBlock II?

The FDA product code for SonoBlock; SonoBlock II 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 K230701Stim2Go

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 K240253達針Aerin Medical, Inc.

官方來源

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