FDA 510(k)

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU

K 號：K202754 · 2021-01-28

決定日期2021-01-28

產品代碼BTY

諮詢委員會AN

決定相當於

器材摘要

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU is the device name listed in this FDA 510(k) record. The listed applicant is Eresearchtechnology GmbH. It received FDA 510(k) clearance on 2021-01-28 under 510(k) number K202754. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU?

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU is a medical device that received FDA 510(k) clearance on 2021-01-28. The listed applicant is Eresearchtechnology GmbH. The 510(k) number is K202754.

When did MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU receive FDA 510(k) clearance?

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU received FDA 510(k) clearance on 2021-01-28, under 510(k) number K202754.

Who is the listed applicant for MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU?

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

What is the FDA product code for MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU?

The FDA product code for MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU is BTY.

其他以 Eresearchtechnology GmbH 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。

K223629SpіroSphere，SpіroSphereECG，CardіoSphere K173937斯匹羅球

相關器械（代碼：BTY）

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。

K260242CPETWise 平臺Medibyt , Ltd.K242809Ascent 心肺診斷軟體Medical Graphics Corporation K223629SpіroSphere，SpіroSphereECG，CardіoSphereEresearchtechnology GmbH K231561肺功能測試儀，型號：A9Guangzhou Homesun Medical Technology Co., Ltd.K222982Virtus代謝監測器Virtus Technology Aps K2210309100 型號肺功能測試/氣道內視鏡設備Vitalograph Ireland, 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。