Product code MLO
- Device name
- Electrocardiograph, Ambulatory, With Analysis Algorithm
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2800
- 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 |
|---|---|---|---|
| K241890 | Philips Holter Analysis System | Philips Medizin Systeme Böblingen GmbH | 2025-03-21 |
| K240794 | Frontier X Plus | Fourth Frontier Technologies Pvt, Ltd. | 2024-11-08 |
| K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | 2020-09-02 |
| K193177 | CER-S | Cardiocalm | 2020-08-26 |
| K182030 | Faros Mobile | Bittium Biosignals , Ltd. | 2018-11-08 |
| K140847 | CARDIOSPY ECG HOLTER SYSTEMS | Labtech Kft. | 2014-12-05 |
| K131897 | CV3000 HOLTER ANALYSIS SYSTEM | Vales & Hills Biomedical Tech. , Ltd. | 2013-11-26 |
| K130660 | AUDICOR CPAM WITH SDB (SINGLE SENSOR) | Inovise Medical, Inc. | 2013-10-11 |
| K120462 | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) | Inovise Medical, Inc. | 2012-09-20 |
| K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | Norav Medical Corp. | 2011-11-10 |
| K110569 | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) | Inovise Medical, Inc. | 2011-10-24 |
| K101273 | DYNAMIC ECG SYSTEM MODEL TLC5000 | Contec Medical System Co., Ltd. | 2011-09-30 |
| K092853 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM | Galix Biomedical Instrumentation, Inc. | 2010-07-09 |
| K063339 | MEDICK MHM200 PERSONAL HEART MONITOR | Medick Healthcare , Ltd. | 2007-06-29 |
| K062088 | PREMIER 11 HOLTER | Diagnostic Monitoring Software | 2006-08-25 |
| K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | Global Instrumentation, LLC | 2005-09-26 |
| K042782 | SEER MC | Ge Medical Systems Information Technologies | 2005-09-02 |
| K043454 | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 | Medicomp, Inc. | 2005-03-24 |
| K042108 | VISTA PLUS | Novacor | 2005-01-19 |
| K040753 | R-TEST EVOLUTION 3 | Novacor | 2004-06-10 |
| K024323 | CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 | Biomedical Systems Corp. | 2003-06-30 |
| K031466 | IQMARK DIGITAL HOLTER | Brentwood Medical Technology Corp. | 2003-06-11 |
| K012712 | NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 | Norav Medical , Ltd. | 2002-05-08 |
| K010396 | C. NET 2100 | Cardionetics, Ltd. | 2001-10-04 |
| K010949 | 2010 PLUS HOLTER FOR WINDOWS | Agilent Technologies | 2001-09-28 |
| K004017 | H-SCRIBE | Mortara Instrument, Inc. | 2001-06-11 |
| K992706 | GALIX GBI -3S-LP | Galix Biomedical Instrumentation, Inc. | 2001-03-15 |
| K003940 | 2010 PLUS HOLTER FOR WINDOWS | Agilent Technologies | 2001-02-08 |
| K003763 | 2010 PLUS HOLTER FOR WINDOWS | Agilent Technologies | 2001-01-05 |
| K993788 | R.TEST EVOLUTION | Novacor Div. | 2000-08-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800069700260 | AT-Patch | ATsens Co., Ltd. | 2025-11-05 |
| 08800069700277 | AT-Patch | ATsens Co., Ltd. | 2025-11-05 |
| 08800069700109 | AT-Report | ATsens Co., Ltd. | 2025-11-05 |
| 00817111021332 | Polysmith | Neurotronics, LLC | 2025-09-23 |
| 00817111021257 | Polysmith Version 12.2 | Neurotronics, LLC | 2022-12-28 |
| B146ER9WCNC0 | ER9W CDMA wEvent | BRAEMAR MANUFACTURING, LLC | 2020-07-15 |
| B146ERWCD020 | ER9W CDMA First Call Med | BRAEMAR MANUFACTURING, LLC | 2020-07-15 |
| B146ERWCD030 | ER9W CDMA UNM | BRAEMAR MANUFACTURING, LLC | 2020-07-15 |
| 00817111021172 | Polysmith Version 12.0 | Neurotronics, LLC | 2020-04-01 |
| B146ERW3G020 | ER9W 3GSM Brookings | BRAEMAR MANUFACTURING, LLC | 2019-10-08 |
| B146ERW3GCN0 | ER9W wEvent 3GSM | BRAEMAR MANUFACTURING, LLC | 2019-10-08 |
| B146ERWCD040 | ER9W Cardiolabs | BRAEMAR MANUFACTURING, LLC | 2019-10-08 |
| B146ERWCD050 | ER9W Cardiomedix | BRAEMAR MANUFACTURING, LLC | 2019-10-08 |
| 00817655022338 | Modality Manager | MORTARA INSTRUMENT, INC. | 2017-10-11 |
| 00817655022314 | Modality Manager | MORTARA INSTRUMENT, INC. | 2017-10-11 |
| 00817655022291 | Modality Manager | MORTARA INSTRUMENT, INC. | 2017-10-11 |
| 00817111020779 | Polysmith Version 11.0 | Neurotronics, LLC | 2017-03-10 |
| 00812345027365 | Scribe | MORTARA INSTRUMENT, INC. | 2016-09-24 |
| 00812345027372 | Scribe | MORTARA INSTRUMENT, INC. | 2016-09-24 |
| 00812345027426 | Modality Manager | MORTARA INSTRUMENT, INC. | 2016-09-24 |
| 00812345027433 | Modality Manager | MORTARA INSTRUMENT, INC. | 2016-09-24 |
| 00812345027440 | Modality Manager | MORTARA INSTRUMENT, INC. | 2016-09-24 |
| 00812345027457 | Modality Manager | MORTARA INSTRUMENT, INC. | 2016-09-24 |
| 00812345027464 | Modality Manager | MORTARA INSTRUMENT, INC. | 2016-09-24 |
| 00812345027358 | Scribe | MORTARA INSTRUMENT, INC. | 2016-09-24 |
| 00812345027341 | Scribe | MORTARA INSTRUMENT, INC. | 2016-09-24 |
| 00812345027327 | Scribe | MORTARA INSTRUMENT, INC. | 2016-09-24 |
| 00812345027310 | Scribe | MORTARA INSTRUMENT, INC. | 2016-09-24 |
| 00812345027297 | Scribe | MORTARA INSTRUMENT, INC. | 2016-09-24 |
| 10841709100687 | Midmark IQholter® Electrodes | MIDMARK CORPORATION | 2016-09-24 |