FDA 510(k)

確認藥物注射式心臟監護器

K 號：K190295 · 2019-04-10

決定日期2019-04-10

產品代碼MXC

諮詢委員會履歷

決定相當於

器材摘要

Confirm Rx Insertable Cardiac Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Abbott (St. Jude Medical). It received FDA 510(k) clearance on 2019-04-10 under 510(k) number K190295. The device is classified under product code MXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Confirm Rx Insertable Cardiac Monitor?

Confirm Rx Insertable Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2019-04-10. The listed applicant is Abbott (St. Jude Medical). The 510(k) number is K190295.

When did Confirm Rx Insertable Cardiac Monitor receive FDA 510(k) clearance?

Confirm Rx Insertable Cardiac Monitor received FDA 510(k) clearance on 2019-04-10, under 510(k) number K190295.

Who is the listed applicant for Confirm Rx Insertable Cardiac Monitor?

The FDA 510(k) record lists Abbott (St. Jude Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Confirm Rx Insertable Cardiac Monitor?

The FDA product code for Confirm Rx Insertable Cardiac Monitor is MXC.

其他以 Abbott (St. Jude Medical) 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。

K212206Jot Dx 可植入式心臟監測器 K202876確認藥物注射式心臟監護器 K202888確認藥物注射式心臟監護器 K200721Agilis HisPro Steerable Catheter With Electrodes K193310我的梅林手機應用程式（Android），我的梅林手機應用程式（iOS）

相關器械（代碼：MXC）

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。

K230286Assert-IQ® 插入式心臟監護器ABBOTT MEDICAL K212206Jot Dx 可植入式心臟監測器Abbott (St. Jude Medical)K202876確認藥物注射式心臟監護器Abbott (St. Jude Medical)K202888確認藥物注射式心臟監護器Abbott (St. Jude Medical)K193310我的梅林手機應用程式（Android），我的梅林手機應用程式（iOS）Abbott (St. Jude Medical)K192593確認藥物注射式心臟監護器Abbott

官方來源

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