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FDA 510(k)

BEAR 2 身體

K 號:K232242 · 2024-05-13

申請人Foreo, Inc.
決定日期2024-05-13
產品代碼NFO
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

BEAR 2 Body is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2024-05-13 under 510(k) number K232242. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BEAR 2 Body?

BEAR 2 Body is a medical device that received FDA 510(k) clearance on 2024-05-13. The listed applicant is Foreo, Inc.. The 510(k) number is K232242.

When did BEAR 2 Body receive FDA 510(k) clearance?

BEAR 2 Body received FDA 510(k) clearance on 2024-05-13, under 510(k) number K232242.

Who is the listed applicant for BEAR 2 Body?

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 BEAR 2 Body?

The FDA product code for BEAR 2 Body is NFO.

其他以 Foreo, Inc. 為申請人之記錄

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相關器械(代碼:NFO)

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