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FDA 510(k)

我的梅林手機應用程式（Android），我的梅林手機應用程式（iOS）

K 號：K193310 · 2020-03-17

申請人Abbott (St. Jude Medical)
決定日期2020-03-17
產品代碼MXC
諮詢委員會履歷
決定相當於

器材摘要

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) 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 2020-03-17 under 510(k) number K193310. 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 myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)?

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) is a medical device that received FDA 510(k) clearance on 2020-03-17. The listed applicant is Abbott (St. Jude Medical). The 510(k) number is K193310.

When did myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) receive FDA 510(k) clearance?

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) received FDA 510(k) clearance on 2020-03-17, under 510(k) number K193310.

Who is the listed applicant for myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)?

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 myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)?

The FDA product code for myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) is MXC.

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

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 ElectrodesK190295確認藥物注射式心臟監護器

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 MEDICALK212206Jot 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)K192593確認藥物注射式心臟監護器AbbottK190295確認藥物注射式心臟監護器Abbott (St. Jude Medical)

官方來源

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