FDA 510(k)

F3 醫療設備規範文本翻譯： F3 注意事項：在翻譯過程中，已保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別碼和網址。遵循政策：medical-regulatory-v1。以下為翻譯結果。

K 號：K222998 · 2023-06-20

決定日期2023-06-20

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

F3 is the device name listed in this FDA 510(k) record. The listed applicant is Acrew Imaging, Inc.. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K222998. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the F3?

F3 is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Acrew Imaging, Inc.. The 510(k) number is K222998.

When did F3 receive FDA 510(k) clearance?

F3 received FDA 510(k) clearance on 2023-06-20, under 510(k) number K222998.

Who is the listed applicant for F3?

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

What is the FDA product code for F3?

The FDA product code for F3 is OWB.

相關器械（代碼：OWB）

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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