FDA 510(k)

康乃馨行動監測器

K 號：K191471 · 2019-08-30

決定日期2019-08-30

產品代碼DSH

諮詢委員會履歷

決定相當於

器材摘要

Carnation Ambulatory Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Bardy Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-08-30 under 510(k) number K191471. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Carnation Ambulatory Monitor?

Carnation Ambulatory Monitor is a medical device that received FDA 510(k) clearance on 2019-08-30. The listed applicant is Bardy Diagnostics, Inc.. The 510(k) number is K191471.

When did Carnation Ambulatory Monitor receive FDA 510(k) clearance?

Carnation Ambulatory Monitor received FDA 510(k) clearance on 2019-08-30, under 510(k) number K191471.

Who is the listed applicant for Carnation Ambulatory Monitor?

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

What is the FDA product code for Carnation Ambulatory Monitor?

The FDA product code for Carnation Ambulatory Monitor is DSH.

其他以 Bardy Diagnostics, 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。

K233110康乃馨行動監測器 K210036康乃馨行動監測器（CAM）K200870康乃馨行動監測器 K192556康乃馨行動監測器 K191000康乃馨行動監測器

相關器械（代碼：DSH）

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。

K260157LifeLens生理監測器LifeLens Technologies, Inc.K252389節奏主將心電圖貼片（HM-15BB-AX，HM-15BW-AX，HM-15BW-DX）Smwmed, Inc.K253293VitaloJAK 诊所（型號 7100）Vitalograph , Ltd.K243650Zio® 監護器（DFG0001）iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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。