FDA 510(k)

多參數病人監護儀

K 號：K211619 · 2022-12-29

申請人Shenzhen Comen Medical Instruments Co.,Ltd

決定日期2022-12-29

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Multi-Parameter Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K211619. 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 Multi-Parameter Patient Monitor?

Multi-Parameter Patient Monitor is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. The 510(k) number is K211619.

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

Multi-Parameter Patient Monitor received FDA 510(k) clearance on 2022-12-29, under 510(k) number K211619.

Who is the listed applicant for Multi-Parameter Patient Monitor?

The FDA 510(k) record lists Shenzhen Comen Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multi-Parameter Patient Monitor?

The FDA product code for Multi-Parameter Patient Monitor is MHX.

其他以 Shenzhen Comen Medical Instruments Co.,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。

K250854多參數病人監護儀（N10）；多參數病人監護儀（N12）；多參數病人監護儀（N15）；多參數病人監護儀（N10MPro）；多參數病人監護儀（N12MPro）；多參數病人監護儀（N15MPro）K250190連續壓縮系統（SCD600）K191106C50及C80多參數病人監護儀 K173454多參數病人監護儀，型號C30

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

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