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FDA 510(k)

常見問題 101

K 號:K222012 · 2023-04-05

申請人Foreo, Inc.
決定日期2023-04-05
產品代碼PAY
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

FAQ 101 is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K222012. The device is classified under product code PAY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FAQ 101?

FAQ 101 is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Foreo, Inc.. The 510(k) number is K222012.

When did FAQ 101 receive FDA 510(k) clearance?

FAQ 101 received FDA 510(k) clearance on 2023-04-05, under 510(k) number K222012.

Who is the listed applicant for FAQ 101?

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

What is the FDA product code for FAQ 101?

The FDA product code for FAQ 101 is PAY.

其他以 Foreo, Inc. 為申請人之記錄

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相關器械(代碼:PAY)

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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