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FDA 510(k)

CytonPro-5000

K 號:K213524 · 2022-08-10

決定日期2022-08-10
產品代碼ILY
諮詢委員會PM
決定相當於

器材摘要

CytonPro-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Cytonsys, Inc.. It received FDA 510(k) clearance on 2022-08-10 under 510(k) number K213524. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CytonPro-5000?

CytonPro-5000 is a medical device that received FDA 510(k) clearance on 2022-08-10. The listed applicant is Cytonsys, Inc.. The 510(k) number is K213524.

When did CytonPro-5000 receive FDA 510(k) clearance?

CytonPro-5000 received FDA 510(k) clearance on 2022-08-10, under 510(k) number K213524.

Who is the listed applicant for CytonPro-5000?

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

What is the FDA product code for CytonPro-5000?

The FDA product code for CytonPro-5000 is ILY.

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相關器械(代碼:ILY)

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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