FDA 510(k)

心臟觸發監測器

K 號：K202138 · 2021-05-14

決定日期2021-05-14

產品代碼DRT

諮詢委員會履歷

決定相當於

器材摘要

Cardiac Trigger Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2021-05-14 under 510(k) number K202138. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cardiac Trigger Monitor?

Cardiac Trigger Monitor is a medical device that received FDA 510(k) clearance on 2021-05-14. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K202138.

When did Cardiac Trigger Monitor receive FDA 510(k) clearance?

Cardiac Trigger Monitor received FDA 510(k) clearance on 2021-05-14, under 510(k) number K202138.

Who is the listed applicant for Cardiac Trigger Monitor?

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

What is the FDA product code for Cardiac Trigger Monitor?

The FDA product code for Cardiac Trigger Monitor is DRT.

其他以 Ivy Biomedical Systems, 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。

K240087RT碳電極心電圖 K203653MRI PPG 患者連線 K192852MRI ECG 病患連線 K171778MR無線閉鎖系統，型號WGS-100 K170828心臟觸發監測器 K151781心臟觸發監測器，心臟與規範同步監測器

查看所有 7 項裝置 →

相關器械（代碼：DRT）

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。

K254058DistaSense™ (v1)Life Detection Technologies K261286Circadia C300 系統（C300）Circadia Health, Inc.K252676Circadia C300 系統（C300）Circadia Health, Inc.K253388Sleepiz One+（型號 2.5）Sleepiz AG K251364Sleepiz One+ (2.5)Sleepiz AG K234003Circadia C200 系統Circadia Technologies, 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。