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FDA 510(k)

TRAP EASY 注意事項:本產品為醫療設備,需遵守相關醫療設備規範。該產品已通過美國食品藥品管理局(FDA)的510(k)認證,並獲得PMA許可。相關研究已登錄於NCT和PMID。詳細資訊請參考以下網址:[URL]。

K 號:K242029 · 2024-10-09

決定日期2024-10-09
產品代碼KNW
諮詢委員會GU
決定相當於

器材摘要

TRAP EASY is the device name listed in this FDA 510(k) record. The listed applicant is H.S Hospital Service S.P.A. It received FDA 510(k) clearance on 2024-10-09 under 510(k) number K242029. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TRAP EASY?

TRAP EASY is a medical device that received FDA 510(k) clearance on 2024-10-09. The listed applicant is H.S Hospital Service S.P.A. The 510(k) number is K242029.

When did TRAP EASY receive FDA 510(k) clearance?

TRAP EASY received FDA 510(k) clearance on 2024-10-09, under 510(k) number K242029.

Who is the listed applicant for TRAP EASY?

The FDA 510(k) record lists H.S Hospital Service S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAP EASY?

The FDA product code for TRAP EASY is KNW.

其他以 H.S Hospital Service S.P.A 為申請人之記錄

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相關器械(代碼:KNW)

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。

官方來源

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