FDA 510(k)

SonoPlex STIM；SonoPlex II

K 號：K243682 · 2025-06-27

決定日期2025-06-27

產品代碼BSP

諮詢委員會AN

決定相當於

器材摘要

SonoPlex STIM; SonoPlex 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 2025-06-27 under 510(k) number K243682. 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 SonoPlex STIM; SonoPlex II?

SonoPlex STIM; SonoPlex II is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K243682.

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

SonoPlex STIM; SonoPlex II received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243682.

Who is the listed applicant for SonoPlex STIM; SonoPlex 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 SonoPlex STIM; SonoPlex II?

The FDA product code for SonoPlex STIM; SonoPlex 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 K250774SPROTTE® 标準 (LUER/NRFit®) 腰椎穿刺 K243525SonoTAP 及 SonoTAP II K241953SPROTTE®標準（LUER/NRFit®）麻醉學 K241954SonoBlock；SonoBlock II 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 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 K240253達針Aerin Medical, Inc.

官方來源

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