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FDA 510(k)

MFG-05

K 號:K230780 · 2023-10-05

決定日期2023-10-05
產品代碼KPI
諮詢委員會GU
決定相當於

器材摘要

MFG-05 is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K230780. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MFG-05?

MFG-05 is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K230780.

When did MFG-05 receive FDA 510(k) clearance?

MFG-05 received FDA 510(k) clearance on 2023-10-05, under 510(k) number K230780.

Who is the listed applicant for MFG-05?

The FDA 510(k) record lists Zimmer Medizinsysteme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MFG-05?

The FDA product code for MFG-05 is KPI.

其他以 Zimmer Medizinsysteme GmbH 為申請人之記錄

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相關器械(代碼:KPI)

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官方來源

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