FDA 510(k)

北視覺多參數病人監護儀

K 號：K173036 · 2018-12-21

決定日期2018-12-21

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

North-vision Multi-parameter Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is North-Vision Tech., Inc.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K173036. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the North-vision Multi-parameter Patient Monitor?

North-vision Multi-parameter Patient Monitor is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is North-Vision Tech., Inc.. The 510(k) number is K173036.

When did North-vision Multi-parameter Patient Monitor receive FDA 510(k) clearance?

North-vision Multi-parameter Patient Monitor received FDA 510(k) clearance on 2018-12-21, under 510(k) number K173036.

Who is the listed applicant for North-vision Multi-parameter Patient Monitor?

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

What is the FDA product code for North-vision Multi-parameter Patient Monitor?

The FDA product code for North-vision Multi-parameter Patient Monitor is MHX.

相關器械（代碼：MHX）

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。

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland Oy K260343Carescape Canvas 1000；Carescape Canvas 智能顯示器GE Healthcare Finland Oy K260579Infinity® 急性照護系統 (IACS) – VG8.1Draeger Medical Systems, Inc.K251508遙測監視器（iT30，iT50）Edan Instruments, Inc.K253277監視器 B105M；監視器 B125M；監視器 B155M；監視器 B105P；監視器 B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM 及其附件Masimo Corporation

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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：MHX）

官方來源