FDA 510(k)

觀-PAT200U

K 號：K153070 · 2016-07-26

決定日期2016-07-26

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

Watch-PAT200U 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 2016-07-26 under 510(k) number K153070. 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 Watch-PAT200U?

Watch-PAT200U is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Itamar Medical , Ltd.. The 510(k) number is K153070.

When did Watch-PAT200U receive FDA 510(k) clearance?

Watch-PAT200U received FDA 510(k) clearance on 2016-07-26, under 510(k) number K153070.

Who is the listed applicant for Watch-PAT200U?

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 Watch-PAT200U?

The FDA product code for Watch-PAT200U 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)K203839WatchPAT200U (WP200U)

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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

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