FDA 510(k)

myPatch-s 医療設備規範文本 myPatch-s 医療設備註冊文獻 myPatch-s 製品註冊資料 myPatch-s 製品許可證 FDA、510(k)、PMA、NCT、PMID、識別碼及網址規範：醫療註冊-v1

K 號：K160704 · 2016-07-15

決定日期2016-07-15

產品代碼DSH

諮詢委員會履歷

決定相當於

器材摘要

myPatch-s is the device name listed in this FDA 510(k) record. The listed applicant is Dms-Service, LLC. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K160704. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the myPatch-s?

myPatch-s is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Dms-Service, LLC. The 510(k) number is K160704.

When did myPatch-s receive FDA 510(k) clearance?

myPatch-s received FDA 510(k) clearance on 2016-07-15, under 510(k) number K160704.

Who is the listed applicant for myPatch-s?

The FDA 510(k) record lists Dms-Service, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for myPatch-s?

The FDA product code for myPatch-s is DSH.

其他以 Dms-Service, LLC 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。

K163535我的貼片 sl

相關器械（代碼：DSH）

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。

K260157LifeLens生理監測器LifeLens Technologies, Inc.K252389節奏主將心電圖貼片（HM-15BB-AX，HM-15BW-AX，HM-15BW-DX）Smwmed, Inc.K253293VitaloJAK 诊所（型號 7100）Vitalograph , Ltd.K243650Zio® 監護器（DFG0001）iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., 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。