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)
Top companies in DSI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2012 | Spacelabs 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 |
DSI | K842616 |
| Apr 13, 2012 | Scottcare 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 |
DSI | K092947 |
| Jan 17, 2012 | Spacelabs 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 |
DSI | K103142 |
| Jan 11, 2012 | Spacelabs 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 |
DSI | K103142 |
| Aug 3, 2011 | Welch 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 |
DSI | K052160 |
| Jul 14, 2011 | Brentwood 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 |
DSI | K955023 |
| Jul 14, 2011 | Brentwood 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 |
DSI | K955023 |
| Jul 14, 2011 | Brentwood 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 |
DSI | K955023 |
| Nov 12, 2010 | Welch 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 |
DSI | K052160 |
| Oct 8, 2010 | Philips 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 |
DSI | K023698 |
| Sep 29, 2010 | Philips 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 |
DSI | K083517 |
| Sep 29, 2010 | Philips 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 |
DSI | K082633 |
| Sep 4, 2009 | GE 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 |
DSI | K062976 |
| May 4, 2009 | GE 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 |
DSI | K032370 K053356 +1 |
| Jan 13, 2009 | Philips 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 |
DSI | K082633 |
| Jan 5, 2009 | GE 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 |
DSI | K012467 |
| Sep 25, 2008 | Spacelabs 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 |
DSI | None listed |
| Sep 20, 2008 | Spacelabs 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 |
DSI | K972502 |
| Sep 19, 2008 | Spacelabs 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 |
DSI | K972502 |
| Sep 19, 2008 | Spacelabs 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 |
DSI | K972502 |
| Sep 18, 2008 | Spacelabs 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 |
DSI | K925510 |
| Feb 1, 2008 | General 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 |
DSI | K032370 |
| Jan 17, 2008 | General 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 |
DSI | K062976 |
| Jun 6, 2007 | General 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 |
DSI | K032370 |
| Feb 27, 2007 | Spacelabs Healthcare, Incorporated Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor. Terminated |
DSI | K050605 |
| Jul 6, 2006 | Spacelabs 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 |
DSI | K925510 |
| Nov 3, 2005 | Spacelabs Medical Incorporated Tru-Link DIN unshielded ECG cable, 5-lead Terminated |
DSI | K842616 |
| Oct 21, 2004 | General Electric Medical Systems Information Technology GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6 Terminated |
DSI | K032370 |
| Jul 20, 2004 | Spacelabs Medical Inc. Ultraview 1700 Monitor Model 90387. Terminated |
DSI | None listed |
| Jul 20, 2004 | Spacelabs Medical Inc. Ultraview Universal Clinical Workstation Model 90385. Terminated |
DSI | None listed |
| Feb 13, 2004 | Welch Allyn Protocol, Inc Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00 Terminated |
DSI | K022453 |
| Nov 6, 2003 | General Electric Medical Systems Information Technology Solar 8000M Patient Monitor with software versions 3A, 3B and 3C Terminated |
DSI | None listed |
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