ClearanceBrief
Panels › Cardiovascular › Product code DSI · Class 2

Detector And Alarm, Arrhythmia

Regulation 870.1025

1510(k)s in 12 months (398 all time)
20recalls in 12 months (82 all time)
78recalls that name a 510(k)
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Top companies in DSI

DateFirm and productCodeLinked 510(k)
Sep 14, 2012Spacelabs Healthcare, Llc
Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter
Terminated
DSIK842616
Apr 13, 2012Scottcare Corporation
TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare Corporation, Cleveland, OH. The TeleSentry device is intended for diagnostic evaluation of patients who experience t
Terminated
DSIK092947
Jan 17, 2012Spacelabs Healthcare, Llc
Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process va
Terminated
DSIK103142
Jan 11, 2012Spacelabs Healthcare, Llc
Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters
Terminated
DSIK103142
Aug 3, 2011Welch Allyn Protocol, Inc
Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System. Welch Allyn Protocol, Inc. Intended for use by clinicians for the central monitoring of neonatal, pedi
Terminated
DSIK052160
Jul 14, 2011Brentwood Medical Technology Corp
IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0 IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface.
Terminated
DSIK955023
Jul 14, 2011Brentwood Medical Technology Corp
IQecg IQmanager Diagnostic Workstation, Part Numbers: 4-100-1200, Software Version 8.0.1, 8.3, 8.3.1, 8.3.2 IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms fro
Terminated
DSIK955023
Jul 14, 2011Brentwood Medical Technology Corp
IQecg IQdevices SDK, Part Numbers: 4-100-1403, Software Version 8.3.2 Product Usage: IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surfa
Terminated
DSIK955023
Nov 12, 2010Welch Allyn Protocol, Inc
ViewSonic 19" flat panel LCD display Model VG930M which is used as part of the Welch Allyn Acuity Central Monitoring System. The affected serial numbers are those less than QC2082880001. The ViewSon
Terminated
DSIK052160
Oct 8, 2010Philips Medical Systems North America Co. Phillips
The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm m
Terminated
DSIK023698
Sep 29, 2010Philips Healthcare Inc.
Philips M8102A IntelliVue MP2 Model: 865040 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, re
Terminated
DSIK083517
Sep 29, 2010Philips Healthcare Inc.
Philips M3002A IntelliVue X2 Model: 865039 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, rec
Terminated
DSIK082633
Sep 4, 2009GE Medical Systems Information Tecnology
GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP100 Hardware). The CIC Pro" clinical Information Center central station is intended to collect information fr
Terminated
DSIK062976
May 4, 2009GE Medical Systems Information Tecnology
GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6 ,5.0.7, 5.0.8 and 4.1. The CIC Pro" Clinical Information Center Central Station is intended for use under the direct supervision of a licensed h
Terminated
DSIK032370
K053356 +1
Jan 13, 2009Philips Medical Systems
Philips M8000-64100 Table Mount Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas Modules Gl and G5 and certain options of the IntelliVue Patient Monitors MP5 MPST and MP20/30. Pro
Terminated
DSIK082633
Jan 5, 2009GE Healthcare
GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment
Terminated
DSIK012467
Sep 25, 2008Spacelabs Healthcare, Incorporated
Ultraview Digital Telemetry Transmitter, Model 91341-09 The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal
Terminated
DSINone listed
Sep 20, 2008Spacelabs Healthcare, Incorporated
Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an attached insert card Insert card reads "TruLink series Dual Temperature Cable REF 700-003
Terminated
DSIK972502
Sep 19, 2008Spacelabs Healthcare, Incorporated
Ultraview SL Command Module, Model 91496 The product is intended for use with the Patient Care Monitoring System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or n
Terminated
DSIK972502
Sep 19, 2008Spacelabs Healthcare, Incorporated
Ultraview SL Command Module, Model 90496 The product is intended for use with the Patient Care Monitoring System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or n
Terminated
DSIK972502
Sep 18, 2008Spacelabs Healthcare, Incorporated
Ultraview Digital Telemetry Transmitter, Model 90478 The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal car
Terminated
DSIK925510
Feb 1, 2008General Electric Medical Systems Information Technology
GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (CIC Pro v4.1). GE Medical Systems Information Technologies, Inc., Milwaukee, Wisconsin (System hardware con
Terminated
DSIK032370
Jan 17, 2008General Electric Medical Systems Information Technology
GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems
Terminated
DSIK062976
Jun 6, 2007General Electric Medical Systems Information Technology
GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Information Technologies, Inc., 8200 W. Tower Ave. Milwaukee, Wisconsin USA. (System hard
Terminated
DSIK032370
Feb 27, 2007Spacelabs Healthcare, Incorporated
Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor.
Terminated
DSIK050605
Jul 6, 2006Spacelabs Medical Incorporated
Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver.
Terminated
DSIK925510
Nov 3, 2005Spacelabs Medical Incorporated
Tru-Link DIN unshielded ECG cable, 5-lead
Terminated
DSIK842616
Oct 21, 2004General Electric Medical Systems Information Technology
GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Terminated
DSIK032370
Jul 20, 2004Spacelabs Medical Inc.
Ultraview 1700 Monitor Model 90387.
Terminated
DSINone listed
Jul 20, 2004Spacelabs Medical Inc.
Ultraview Universal Clinical Workstation Model 90385.
Terminated
DSINone listed
Feb 13, 2004Welch Allyn Protocol, Inc
Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00
Terminated
DSIK022453
Nov 6, 2003General Electric Medical Systems Information Technology
Solar 8000M Patient Monitor with software versions 3A, 3B and 3C
Terminated
DSINone listed

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