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)

Cardio-TriTest v6.5

K 號：K182790 · 2018-12-14

申請人Cardio-Phoenix, Inc.
決定日期2018-12-14
產品代碼DPS
諮詢委員會履歷
決定相當於

器材摘要

Cardio-TriTest v6.5 is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Phoenix, Inc.. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182790. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cardio-TriTest v6.5?

Cardio-TriTest v6.5 is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Cardio-Phoenix, Inc.. The 510(k) number is K182790.

When did Cardio-TriTest v6.5 receive FDA 510(k) clearance?

Cardio-TriTest v6.5 received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182790.

Who is the listed applicant for Cardio-TriTest v6.5?

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

What is the FDA product code for Cardio-TriTest v6.5?

The FDA product code for Cardio-TriTest v6.5 is DPS.

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：DPS）

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。

K254255S-Patch 心臟AIWellysis Corp.K252463SE-1202系列心電圖儀（型號：SE-1202，SE-1202E）Edan Instruments, Inc.K251670MAC 7 靜息心電圖分析系統Ge Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs 霍爾特平台Philips France Commercial

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。

↑