Product code MLD
- Device name
- Monitor, St Segment With Alarm
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1025
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101602 | VITAL SIGNS MONITOR | Criticare Systems, Inc. | 2010-09-01 |
| K080461 | STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 | Philips Medical Systems | 2008-03-13 |
| K022740 | DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE | Datex-Ohmeda | 2002-11-14 |
| K012837 | MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES | Datex-Ohmeda | 2001-09-14 |
| K002105 | SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS | Siemens Medical Solutions USA, Inc. | 2000-12-05 |
| K992323 | DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES | Datex-Ohmeda, Inc. | 1999-11-01 |
| K982104 | ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 | Medical Data Electronics | 1998-11-25 |
| K974492 | SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS | Siemens Medical Solutions USA, Inc. | 1998-02-26 |
| K972121 | ACUITY CENTRAL STATION | Protocol Systems, Inc. | 1997-11-07 |
| K953175 | AS/3 ESTPR MODULE | Datex Division Instrumentarium Corp. | 1997-02-06 |
| K960272 | EAGLE 3000/3100 PATIENT MONITOR | Marquette Electronics, Inc. | 1996-10-02 |
| K960934 | HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 | Hewlett-Packard Co. | 1996-06-14 |
| K935020 | OMNI-TRAC MODIFICATION | Invivo Research, Inc. | 1995-04-26 |
| K920429 | MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM | Hewlett-Packard Co. | 1993-07-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B510PMMAX13 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2024-12-19 |
| 10841522117688 | XHIBIT | SPACELABS HEALTHCARE (WASHINGTON), INC | 2024-06-07 |
| 00195278524089 | NA | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278523365 | CARESCAPE Canvas D19 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278522320 | CARESCAPE Canvas 1000 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278466679 | N-EEGX | GE Healthcare Finland Oy | 2022-07-01 |
| 00195278466662 | E-EEGX | GE Healthcare Finland Oy | 2022-07-01 |
| 00195278288639 | CARESCAPE ONE | Ge Medical Systems Information Technologies, Inc. | 2022-05-13 |
| B510PM2000XLPRO1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000XLPLUS1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000XL1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000TM1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000M1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| 10841522127069 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2019-04-01 |
| B3943950010000 | Athena GTX Device Management Suite (ADMS) Software | ATHENA GTX, INC. | 2018-04-20 |
| 10841522102875 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-02-03 |
| 20884838072248 | Spirometry Sensor | Philips Medizin Systeme Böblingen GmbH | 2017-01-20 |
| 10841522120275 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-06 |
| 10841522120268 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-06 |
| 10841522120251 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-06 |
| 10841522120244 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-06 |
| 10841522120220 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-06 |
| 10841522120213 | Ultraview SL® | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-06 |
| 10841522120206 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522102714 | XTR | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522107160 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-04 |
| 10841522100345 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-04 |
| 10841522100246 | Xhibit Telemetry Receiver | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-09-22 |
| 10841522107177 | XTR | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-09-22 |
| 10841522106514 | XTR | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-09-22 |