FDA 510(k)

我的梅林™移動應用程式模型 APP1001

K 號：K173232 · 2017-11-02

決定日期2017-11-02

產品代碼MXC

諮詢委員會履歷

決定相當於

器材摘要

myMerlin(TM) Mobile Application Model APP1001 is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2017-11-02 under 510(k) number K173232. 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(TM) Mobile Application Model APP1001?

myMerlin(TM) Mobile Application Model APP1001 is a medical device that received FDA 510(k) clearance on 2017-11-02. The listed applicant is St Jude Medical. The 510(k) number is K173232.

When did myMerlin(TM) Mobile Application Model APP1001 receive FDA 510(k) clearance?

myMerlin(TM) Mobile Application Model APP1001 received FDA 510(k) clearance on 2017-11-02, under 510(k) number K173232.

Who is the listed applicant for myMerlin(TM) Mobile Application Model APP1001?

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

What is the FDA product code for myMerlin(TM) Mobile Application Model APP1001?

The FDA product code for myMerlin(TM) Mobile Application Model APP1001 is MXC.

其他以 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。

K181382守護者™ 體外孔蓋系統 K172396EnSite Velocity 心臟電位圖系統 v5.2 K160335Advisor FL 15mm 12 极 333 Uni D, Advisor FL 20mm 12 极 555 Uni D, Advisor FL 15mm 12 极 333 Bi D, Advisor FL 20mm 12 极 555 Bi D K162643醫導科技系統 K160218AutoMark 模組 K160210EnSite精準心臟映射系統 v2.0

查看所有 11 項裝置 →

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

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。