FDA 510(k)

病人監護儀

K 號：K152552 · 2016-04-29

決定日期2016-04-29

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K152552. 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 Patient Monitor?

Patient Monitor is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K152552.

When did Patient Monitor receive FDA 510(k) clearance?

Patient Monitor received FDA 510(k) clearance on 2016-04-29, under 510(k) number K152552.

Who is the listed applicant for Patient Monitor?

FDA 510(k) 記錄將 Edan Instruments, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Patient Monitor?

The FDA product code for Patient Monitor is MHX.

其他以 Edan Instruments, Inc. 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。

K251508遙測監視器（iT30，iT50）K252463SE-1202系列心電圖儀（型號：SE-1202，SE-1202E）K251591霍爾特心電圖與血壓監測系統（HolterABP）K251268診斷超音波系統（Nano C5、Nano C5 EXP、Nano L12 及 Nano L12 EXP）K241882胎兒及母親監護器（F15A，F15A Air）K250179病人監護儀（CX10、CX12、CX15、UX10、UX12、UX15）

查看所有 50 項裝置 →

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。