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FDA 510(k)

PowerCube+ 系列型號 (PowerCube Body+); PowerCube+ 系列型號 (PowerCube Diffusion+); PowerCube+ 系列型號 (PowerCube Body+ / Diffusion+)

K 號：K240706 · 2024-12-09

申請人Ganshorn Medizin Electronic GmbH
決定日期2024-12-09
產品代碼JEH
諮詢委員會AN
決定相當於

器材摘要

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) is the device name listed in this FDA 510(k) record. The listed applicant is Ganshorn Medizin Electronic GmbH. It received FDA 510(k) clearance on 2024-12-09 under 510(k) number K240706. The device is classified under product code JEH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) is a medical device that received FDA 510(k) clearance on 2024-12-09. The listed applicant is Ganshorn Medizin Electronic GmbH. The 510(k) number is K240706.

When did PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) receive FDA 510(k) clearance?

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) received FDA 510(k) clearance on 2024-12-09, under 510(k) number K240706.

Who is the listed applicant for PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

The FDA 510(k) record lists Ganshorn Medizin Electronic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

The FDA product code for PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) is JEH.

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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。

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