FDA 510(k)

MCG-S (AM1000)

K 號：K232823 · 2024-04-05

決定日期2024-04-05

產品代碼DPS

諮詢委員會履歷

決定相當於

器材摘要

MCG-S (AM1000) is the device name listed in this FDA 510(k) record. The listed applicant is Amcg Co., Ltd.. It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K232823. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MCG-S (AM1000)?

MCG-S (AM1000) is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Amcg Co., Ltd.. The 510(k) number is K232823.

When did MCG-S (AM1000) receive FDA 510(k) clearance?

MCG-S (AM1000) received FDA 510(k) clearance on 2024-04-05, under 510(k) number K232823.

Who is the listed applicant for MCG-S (AM1000)?

The FDA 510(k) record lists Amcg Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MCG-S (AM1000)?

The FDA product code for MCG-S (AM1000) is DPS.

相關器械（代碼：DPS）

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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