免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

COBRA-OS 套件

K 號：K201652 · 2021-02-22

申請人Front Line Medical Technologies, Inc.
決定日期2021-02-22
產品代碼MJN
諮詢委員會履歷
決定Unknown

器材摘要

COBRA-OS Kit is the device name listed in this FDA 510(k) record. The listed applicant is Front Line Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-02-22 under 510(k) number K201652. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常見問題

What is the COBRA-OS Kit?

COBRA-OS Kit is a medical device that received FDA 510(k) clearance on 2021-02-22. The listed applicant is Front Line Medical Technologies, Inc.. The 510(k) number is K201652.

When did COBRA-OS Kit receive FDA 510(k) clearance?

COBRA-OS Kit received FDA 510(k) clearance on 2021-02-22, under 510(k) number K201652.

Who is the listed applicant for COBRA-OS Kit?

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

What is the FDA product code for COBRA-OS Kit?

The FDA product code for COBRA-OS Kit is MJN.

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

相關器械（代碼：MJN）

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。

K243795pREBOA-PRO 管針Prytime Medical Devices, Inc.K251358橋接加壓氣球（590-002）Philips Image Guided Therapy DevicesK221294preCARDIA 閉塞系統Abiomed, Inc.K214060標誌性REBOA導管Zien Medical Technologies, Inc.K211610福吉蒂塞鎖針管Edwards Lifesciences, LLCK212324RenovoCathRenovorx, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑