BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5— 510(k) K092449

Clearance details

Applicant

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Product code

Code MHX

Device class

Class 2

Regulation

21 CFR 870.1025

Advisory panel

Cardiovascular

Date received

2009-08-10

Decision date

2010-08-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Great Neck, NY, US

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Death

580

Injury

2,441

Malfunction

12,655

Other

3

Total

15,679

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2737-2015 — Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.Class II·Terminated·Mindray DS USA, Inc. dba Mindray North America·20150727
• Z-0837-2015 — DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.Class II·Terminated·Mindray DS USA, Inc. dba Mindray North America·20141006
• Z-1611-2014 — DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)Class II·Terminated·Mindray DS USA, Inc. dba Mindray North America·20140305
• Z-0513-2013 — DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).Class II·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·20100811

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092449.