FDA 510(k)

JetCan® Pro 安全針頭

K 號：K242763 · 2025-05-02

決定日期2025-05-02

產品代碼FPA

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

JetCan® Pro Safety Huber Needle is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2025-05-02 under 510(k) number K242763. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the JetCan® Pro Safety Huber Needle?

JetCan® Pro Safety Huber Needle is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K242763.

When did JetCan® Pro Safety Huber Needle receive FDA 510(k) clearance?

JetCan® Pro Safety Huber Needle received FDA 510(k) clearance on 2025-05-02, under 510(k) number K242763.

Who is the listed applicant for JetCan® Pro Safety Huber Needle?

The FDA 510(k) record lists Pfm Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JetCan® Pro Safety Huber Needle?

The FDA product code for JetCan® Pro Safety Huber Needle is FPA.

其他以 Pfm Medical, Inc. 為申請人之記錄

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相關器械（代碼：FPA）

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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官方來源

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