FDA 510(k)

遠端心臟監護器

K 號：K161916 · 2016-12-21

決定日期2016-12-21

產品代碼DRG

諮詢委員會履歷

決定相當於

器材摘要

TelePatch Cardiac Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K161916. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TelePatch Cardiac Monitor?

TelePatch Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Medicomp, Inc.. The 510(k) number is K161916.

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

TelePatch Cardiac Monitor received FDA 510(k) clearance on 2016-12-21, under 510(k) number K161916.

Who is the listed applicant for TelePatch Cardiac Monitor?

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

What is the FDA product code for TelePatch Cardiac Monitor?

The FDA product code for TelePatch Cardiac Monitor is DRG.

其他以 Medicomp, 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。

K173170Epicardia 任何處

相關器械（代碼：DRG）

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。

K261569UbiqVue™ 2AYe 心臟系統 (UX2253)Lifesignals, Inc.K252984Perin醫療系統（PHD80060-2）Perin Health Devices, LLC K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259遠端復健 Aermos 心肺復健設備The ScottCare Corporation K243837iBSMIorbit Digital Technologies Private Limited K242018UbiqVue™ 2A 多參數系統 (UX2550)Lifesignals, Inc.

官方來源

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