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FDA 510(k)

ZT醫療中心（MG675A）；ZT立方體（ZC3）（MG465A）；Z-ONE（MG455A）

K 號：K242754 · 2025-05-05

申請人Zamar Medical D.O.O.
決定日期2025-05-05
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) is the device name listed in this FDA 510(k) record. The listed applicant is Zamar Medical D.O.O.. It received FDA 510(k) clearance on 2025-05-05 under 510(k) number K242754. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)?

ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) is a medical device that received FDA 510(k) clearance on 2025-05-05. The listed applicant is Zamar Medical D.O.O.. The 510(k) number is K242754.

When did ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) receive FDA 510(k) clearance?

ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) received FDA 510(k) clearance on 2025-05-05, under 510(k) number K242754.

Who is the listed applicant for ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)?

The FDA 510(k) record lists Zamar Medical D.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)?

The FDA product code for ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) is IRP.

相關臨床試驗

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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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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