FDA 510(k)

AccuCTP

K 號：K220663 · 2022-11-22

決定日期2022-11-22

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

AccuCTP is the device name listed in this FDA 510(k) record. The listed applicant is ArteryFlow Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K220663. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AccuCTP?

AccuCTP is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is ArteryFlow Technology Co., Ltd.. The 510(k) number is K220663.

When did AccuCTP receive FDA 510(k) clearance?

AccuCTP received FDA 510(k) clearance on 2022-11-22, under 510(k) number K220663.

Who is the listed applicant for AccuCTP?

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

What is the FDA product code for AccuCTP?

The FDA product code for AccuCTP is LLZ.

其他以 ArteryFlow Technology Co., Ltd. 為申請人之記錄

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相關器械（代碼：LLZ）

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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