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FDA 510(k)

VascuChek 套件、VascuChek 轨射器、VascuChek 醫學探針、VascuChek 聲音基座（VC-KIT-02、VC-TRX-02、VC-CP-01、VC-SD-01）；VascuChek 套件、VascuChek 轨射器、VascuChek 外科探針、VascuChek 聲音基座（VC-KIT-02、VC-TRX-02、VC-SP-01、VC-SD-01）

K 號：K251904 · 2025-11-20

申請人Remington Medical, Inc.
決定日期2025-11-20
產品代碼DPW
諮詢委員會履歷
決定相當於

器材摘要

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) is the device name listed in this FDA 510(k) record. The listed applicant is Remington Medical, Inc.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K251904. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)?

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Remington Medical, Inc.. The 510(k) number is K251904.

When did VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) receive FDA 510(k) clearance?

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) received FDA 510(k) clearance on 2025-11-20, under 510(k) number K251904.

Who is the listed applicant for VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)?

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

What is the FDA product code for VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)?

The FDA product code for VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) is DPW.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Remington Medical, Inc. 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。

K241583VascuChek 套件、VascuChek 訊號傳送器、VascuChek 醫學探針、VascuChek 充電器（VC-KIT-01、VC-TRX-01、VC-CP-01、VC-CH-01）；VascuChek 套件、VascuChek 訊號傳送器、VascuChek 外科探針、VascuChek 充電器（VC-KIT-01、VC-TRX-01、VC-SP-01、VC-CH-01）K211589VascuChek 套件、VascuChek 訊號傳送器、VascuChek 外科探針、VascuChek 充電器K212065VascuChek 套件、VascuChek 訊號傳送器、VascuChek 醫學探針、VascuChek 充電器K191315Remington醫療股份有限公司自動切割針(NAC)

相關器械（代碼：DPW）

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。

K260700藍多普血管專家BlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek 套件、VascuChek 訊號傳送器、VascuChek 醫學探針、VascuChek 充電器（VC-KIT-01、VC-TRX-01、VC-CP-01、VC-CH-01）；VascuChek 套件、VascuChek 訊號傳送器、VascuChek 外科探針、VascuChek 充電器（VC-KIT-01、VC-TRX-01、VC-SP-01、VC-CH-01）Remington Medical, Inc.K223843FloPatch FP120Flosonics Medical

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