ClearanceBrief
Panels › Cardiovascular › Product code DPS · Class 2

Electrocardiograph

Regulation 870.2340

8510(k)s in 12 months (580 all time)
4recalls in 12 months (98 all time)
89recalls that name a 510(k)
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Top companies in DPS

Company510(k)sRecalls
Smiths Medical PM, Inc.038
Mortara Instrument, Inc.211
Nihon Kohden America, Inc.210
Edan Instruments, Inc.191
Quinton, Inc.170
WELCH ALLYN, INC/MORTARA016
Hewlett-Packard Co.150
Philips North America014
Burdick Corp.120
Philips Medical Systems92
DateFirm and productCodeLinked 510(k)
Jan 21, 2010GE Medical Systems, LLC
GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record informatio
Terminated		 DPSK090212
Jan 30, 2008Philips Medical Systems
Philips PageWriter Touch Cardiograph, Model: 860284, Philips Medical Systems, Andover, MA, 01810
Terminated		 DPSK020708
Nov 6, 2007Medtronic Inc. Cardiac Rhythm Managment
Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Paceart System can act as a Practice Management software application and is intende
Terminated		 DPSK024278
May 31, 2006Medtronic Inc. Cardiac Rhythm Managment
Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal computer based pacemaker-testing system, a 12-l
Terminated		 DPSK024278
Mar 3, 2006Inovise Medical, Inc.
AUDICOR 200 D Inovise Part Number 30047 (console part number 20158).
Terminated		 DPSK043074
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 92E654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 92D754335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 92D654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925754325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925754225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925754220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925674325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925654320, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925534325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925474335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925454335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925454325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925454220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920754235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920655235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920654230, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920634235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated		 DPSK010770
K011177 +2
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 92E654325.
Terminated		 DPSK010770
K011177 +2
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925774325.
Terminated		 DPSK010770
K011177 +2
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335.
Terminated		 DPSK010770
K011177 +2
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674335.
Terminated		 DPSK010770
K011177 +2
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674320.
Terminated		 DPSK010770
K011177 +2
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325.
Terminated		 DPSK010770
K011177 +2
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654220.
Terminated		 DPSK010770
K011177 +2
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925574325.
Terminated		 DPSK010770
K011177 +2
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925554325.
Terminated		 DPSK010770
K011177 +2
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925474325.
Terminated		 DPSK010770
K011177 +2
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654335.
Terminated		 DPSK010770
K011177 +2
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225.
Terminated		 DPSK010770
K011177 +2
Feb 10, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 925474325. Item Description 9200II 3LD/RP/SO/O2/IP/TP BMDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration
Terminated		 DPSK011177
K030407 +1
Feb 10, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II 3LD/RP/O2/IP/TP/PR/B ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration
Terminated		 DPSK011177
K030407 +1
Feb 10, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 92E654325. Item Description 9200 II 3LD/RP/O2/IP/TP/BATT ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiratio
Terminated		 DPSK011177
K030407 +1
Feb 10, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 92E654220. item Description 9200 II 3LD/RSP/SP02 MDD MEDEXL. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiratio
Terminated		 DPSK011177
K030407 +1
Feb 10, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiratio
Terminated		 DPSK011177
K030407 +1
Nov 2, 2004Philips Medical Systems
Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02
Terminated		 DPSK020708
Jul 20, 2004Esaote Biomedica S.P.A.
Esaote brand Formul@ ECG System; part 9704220000.
Terminated		 DPSNone listed
Jul 20, 2004Esaote Biomedica S.P.A.
Esaote brand ArchiWin Colour ECG System; part 9704325000.
Terminated		 DPSNone listed
Jul 20, 2004Esaote Biomedica S.P.A.
Esaote brand Formula for Archimed ECG System; part 9704220000.
Terminated		 DPSNone listed
Jul 20, 2004Esaote Biomedica S.P.A.
Esaote brand Archimed 4220 ECG System; part 9704220000.
Terminated		 DPSNone listed

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