Panels › Cardiovascular › Product code MLD · Class 2
Monitor, St Segment With Alarm
Regulation 870.1025
0510(k)s in 12 months (14 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MLD
| Company | 510(k)s | Recalls |
|---|---|---|
| Datex-Ohmeda | 3 | 0 |
| GE Medical Systems Information Tecnology | 0 | 2 |
| Hewlett-Packard Co. | 2 | 0 |
| Siemens Medical Solutions USA, Inc. | 2 | 0 |
| Criticare Systems, Inc. | 1 | 0 |
| Datex Division Instrumentarium Corp. | 1 | 0 |
| Invivo Research, Inc. | 1 | 0 |
| Marquette Electronics, Inc. | 1 | 0 |
| Medical Data Electronics | 1 | 0 |
| Philips Medical Systems | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 1, 2010 | K101602 | VITAL SIGNS MONITOR Criticare Systems, Inc. | MLD |
| Mar 13, 2008 | K080461 | STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 Philips Medical Systems | MLD |
| Nov 14, 2002 | K022740 | DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE Datex-Ohmeda | MLD |
| Sep 14, 2001 | K012837 | MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES Datex-Ohmeda | MLD |
| Dec 5, 2000 | K002105 | SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS Siemens Medical Solutions USA, Inc. | MLD |
| Nov 1, 1999 | K992323 | DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES Datex-Ohmeda, Inc. | MLD |
| Nov 25, 1998 | K982104 | ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 Medical Data Electronics | MLD |
| Feb 26, 1998 | K974492 | SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS Siemens Medical Solutions USA, Inc. | MLD |
| Nov 7, 1997 | K972121 | ACUITY CENTRAL STATION Protocol Systems, Inc. | MLD |
| Feb 6, 1997 | K953175 | AS/3 ESTPR MODULE Datex Division Instrumentarium Corp. | MLD |
| Oct 2, 1996 | K960272 | EAGLE 3000/3100 PATIENT MONITOR Marquette Electronics, Inc. | MLD |
| Jun 14, 1996 | K960934 | HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 Hewlett-Packard Co. | MLD |
| Apr 26, 1995 | K935020 | OMNI-TRAC MODIFICATION Invivo Research, Inc. | MLD |
| Jul 20, 1993 | K920429 | MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM Hewlett-Packard Co. | MLD |
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