FDA 510(k)

FAQ™ 201, FAQ™ 202

K 號：K240378 · 2024-04-19

決定日期2024-04-19

產品代碼OHS

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™ 201, FAQ™ 202 is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K240378. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FAQ™ 201, FAQ™ 202?

FAQ™ 201, FAQ™ 202 is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Foreo, Inc.. The 510(k) number is K240378.

When did FAQ™ 201, FAQ™ 202 receive FDA 510(k) clearance?

FAQ™ 201, FAQ™ 202 received FDA 510(k) clearance on 2024-04-19, under 510(k) number K240378.

Who is the listed applicant for FAQ™ 201, FAQ™ 202?

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™ 201, FAQ™ 202?

The FDA product code for FAQ™ 201, FAQ™ 202 is OHS.

其他以 Foreo, Inc. 為申請人之記錄

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