ClearanceBrief
Panels › Cardiovascular › Product code DRT · Class 2

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Regulation 870.2300

5510(k)s in 12 months (341 all time)
0recalls in 12 months (11 all time)
10recalls that name a 510(k)
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Top companies in DRT

Company510(k)sRecalls
Hewlett-Packard Co.200
Litton Medical Electronics170
Datascope Corp.75
Ivy Biomedical Systems, Inc.100
Life Science Instrumentation, Inc.100
Nihon Kohden America, Inc.100
S & W Medico Teknik80
Ge Medical Systems Information Technologies60
Honeywell, Inc.60
Rigel Medical Electronics, Inc.60
DateFirm and productCodeLinked 510(k)
Mar 6, 2025Murata Vios, Inc.
Vios Monitoring System Bedside Monitor Model BSM2050
Open, Classified		 DRTK172586
Feb 12, 2025Murata Vios, Inc.
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Open, Classified		 DRTK172586
Jan 30, 2025Murata Vios, Inc.
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Open, Classified		 DRTK172586
Jan 16, 2025Murata Vios, Inc.
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Completed		 DRTK172586
Aug 19, 2014Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheel
Terminated		 DRTK941252
Feb 24, 2012Mindray DS USA, Inc. d.b.a. Mindray North America
V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430 The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG wa
Terminated		 DRTNone listed
Nov 23, 2005Datascope Corp
Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate deri
Terminated		 DRTK020550
Nov 23, 2005Datascope Corp
Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological parameters. The device has a 12.1 inch
Terminated		 DRTK031849
Sep 21, 2005Datascope Corp
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
Terminated		 DRTK031760
Aug 6, 2005Datascope Corp
Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
Terminated		 DRTK031760
Sep 21, 2004Datascope Corp
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
Terminated		 DRTK032338

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