FDA 510(k)

HS AMICA設備系列

K 號：K182605 · 2019-10-28

決定日期2019-10-28

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

HS AMICA devices family 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 2019-10-28 under 510(k) number K182605. 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 HS AMICA devices family?

HS AMICA devices family is a medical device that received FDA 510(k) clearance on 2019-10-28. The listed applicant is H.S Hospital Service S.P.A. The 510(k) number is K182605.

When did HS AMICA devices family receive FDA 510(k) clearance?

HS AMICA devices family received FDA 510(k) clearance on 2019-10-28, under 510(k) number K182605.

Who is the listed applicant for HS AMICA devices family?

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 HS AMICA devices family?

The FDA product code for HS AMICA devices family 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]。K232072AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G

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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