FDA 510(k)

EXTRON 3；EXTRON 5；EXTRON 7

K 號：K250010 · 2025-06-10

決定日期2025-06-10

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

EXTRON 3; EXTRON 5; EXTRON 7 is the device name listed in this FDA 510(k) record. The listed applicant is DRTECH Corporation. It received FDA 510(k) clearance on 2025-06-10 under 510(k) number K250010. 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 EXTRON 3; EXTRON 5; EXTRON 7?

EXTRON 3; EXTRON 5; EXTRON 7 is a medical device that received FDA 510(k) clearance on 2025-06-10. The listed applicant is DRTECH Corporation. The 510(k) number is K250010.

When did EXTRON 3; EXTRON 5; EXTRON 7 receive FDA 510(k) clearance?

EXTRON 3; EXTRON 5; EXTRON 7 received FDA 510(k) clearance on 2025-06-10, under 510(k) number K250010.

Who is the listed applicant for EXTRON 3; EXTRON 5; EXTRON 7?

FDA 510(k) 記錄將 DRTECH Corporation 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for EXTRON 3; EXTRON 5; EXTRON 7?

The FDA product code for EXTRON 3; EXTRON 5; EXTRON 7 is OWB.

其他以 DRTECH Corporation 為申請人之記錄

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。

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH Corporation K254205Zenition 30Philips Medical Systems Nederland B.V.K260607防護系統（西門子 30x40）Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

官方來源

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