FDA 510(k)

WatchPAT200U (WP200U)

K 號：K203839 · 2022-03-21

決定日期2022-03-21

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

WatchPAT200U (WP200U) is the device name listed in this FDA 510(k) record. The listed applicant is Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2022-03-21 under 510(k) number K203839. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WatchPAT200U (WP200U)?

WatchPAT200U (WP200U) is a medical device that received FDA 510(k) clearance on 2022-03-21. The listed applicant is Itamar Medical , Ltd.. The 510(k) number is K203839.

When did WatchPAT200U (WP200U) receive FDA 510(k) clearance?

WatchPAT200U (WP200U) received FDA 510(k) clearance on 2022-03-21, under 510(k) number K203839.

Who is the listed applicant for WatchPAT200U (WP200U)?

FDA 510(k) 記錄將伊塔瑪醫療有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for WatchPAT200U (WP200U)?

The FDA product code for WatchPAT200U (WP200U) is MNR.

其他以 Itamar Medical , Ltd. 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。

K254042觀察者PAT SW K250460WatchPAT400 (WP400)K223675WatchPAT ONE (WP1)K211557EndoPATx K222331WatchPAT300 (WP300)K183559觀察者PAT ONE

查看所有 10 項裝置 →

相關器械（代碼：MNR）

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。

K260949一次性睡眠監測帶（CNSAC）CNSAC Medshop GmbH K254042觀察者PAT SWItamar Medical , Ltd.K260050WRAP系統Huneo, LLC K253148RX-1 睡眠Vivaquant, Inc. Dba Rhythm Express K252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

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。