FDA 510(k)

AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G

K 號：K232072 · 2024-02-09

決定日期2024-02-09

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G 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 2024-02-09 under 510(k) number K232072. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G?

AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is H.S Hospital Service S.P.A. The 510(k) number is K232072.

When did AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G receive FDA 510(k) clearance?

AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G received FDA 510(k) clearance on 2024-02-09, under 510(k) number K232072.

Who is the listed applicant for AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G?

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 AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G?

The FDA product code for AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G is GEI.

其他以 H.S Hospital Service S.P.A 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。

K242029TRAP 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]。K182605HS AMICA設備系列

相關器械（代碼：GEI）

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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