Electrocardiograph, Ambulatory, With Analysis Algorithm
FDA product code MLO · Class II (moderate risk) · 21 CFR 870.2800 · Cardiovascular
33510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Agilent Technologies, Inc. 3
- Inovise Medical, Inc. 3
- Galix Biomedical Instrumentation, Inc. 2
- Norav Medical , Ltd. 2
- Novacor 2
- Zymed Medical Instrumentation 2
- Medicomp, Inc. 1
- Zbeats, Inc. 1
- Bittium Biosignals , Ltd. 1
- Labtech Kft. 1
- Vales & Hills Biomedical Tech. , Ltd. 1
- Contec Medical System Co., Ltd. 1
- Medick Healthcare , Ltd. 1
- Diagnostic Monitoring Software 1
- Global Instrumentation, LLC 1
- Ge Medical Systems Information Technologies 1
- Biomedical Systems Corp. 1
- Brentwood Medical Technology Corp. 1
- Cardionetics, Ltd. 1
- Mortara Instrument, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261580 | ZBPro Diagnostic (Version 2.0)MLO · Traditional | Zbeats, Inc. | 09/11/2026SE |
| K241890 | Philips Holter Analysis SystemMLO · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/21/2025SE |
| K240794 | Frontier X PlusMLO · Traditional | Fourth Frontier Technologies Pvt, Ltd. | 11/08/2024SE |
| K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring SystemMLO · Traditional | VivaQuant, Inc. | 09/02/2020SE |
| K193177 | Cer-SMLO · Traditional | Cardiocalm | 08/26/2020SE |
| K182030 | Faros MobileMLO · Abbreviated | Bittium Biosignals , Ltd. | 11/08/2018SE |
| K140847 | Cardiospy ECG Holter SystemsMLO · Traditional | Labtech Kft. | 12/05/2014SE |
| K131897 | CV3000 Holter Analysis SystemMLO · Traditional | Vales & Hills Biomedical Tech. , Ltd. | 11/26/2013SE |
| K130660 | Audicor Cpam with SDB (Single Sensor)MLO · Traditional | Inovise Medical, Inc. | 10/11/2013SE |
| K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…MLO · Traditional | Inovise Medical, Inc. | 09/20/2012SE |
| K111487 | NH-301 Ambulatory ECG Analysis SoftwareMLO · Special | Norav Medical Corp. | 11/10/2011SE |
| K110569 | Audicor Cpam (Cardiopulmonary Ambulatory Monitor)MLO · Traditional | Inovise Medical, Inc. | 10/24/2011SE |
| K101273 | Dynamic ECG System Model TLC5000MLO · Traditional | Contec Medical System Co., Ltd. | 09/30/2011SE |
| K092853 | 3 Channel Digital Ambulatory ECG Recorder Model Galix GBI-3SMMLO · Traditional | Galix Biomedical Instrumentation, Inc. | 07/09/2010SE |
| K063339 | Medick MHM200 Personal Heart MonitorMLO · Traditional | Medick Healthcare , Ltd. | 06/29/2007SE |
| K062088 | Premier 11 HolterMLO · Special | Diagnostic Monitoring Software | 08/25/2006SE |
| K051730 | Matrix Holter System, Model M12MLO · Abbreviated | Global Instrumentation, LLC | 09/26/2005SE |
| K042782 | Seer MCMLO · Traditional | Ge Medical Systems Information Technologies | 09/02/2005SE |
| K043454 | Cardiopal Ai with Diogenes SV (Cardiopal SV), Model PM410MLO · Special | Medicomp, Inc. | 03/24/2005SE |
| K042108 | Vista PlusMLO · Traditional | Novacor | 01/19/2005SE |
| K040753 | R-Test Evolution 3MLO · Special | Novacor | 06/10/2004SE |
| K024323 | Century Series Holter Scanner System, Models C3000, C2000 and C1000MLO · Traditional | Biomedical Systems Corp. | 06/30/2003SE |
| K031466 | Iqmark Digital HolterMLO · Special | Brentwood Medical Technology Corp. | 06/11/2003SE |
| K012712 | Norav Holter System, Model NH-300 V1.07MLO · Traditional | Norav Medical , Ltd. | 05/08/2002SE |
| K010396 | C. Net 2100MLO · Traditional | Cardionetics, Ltd. | 10/04/2001SE |
| K010949 | 2010 Plus Holter for WindowsMLO · Traditional | Agilent Technologies | 09/28/2001SE |
| K004017 | H-ScribeMLO · Traditional | Mortara Instrument, Inc. | 06/11/2001SE |
| K992706 | Galix Gbi -3S-LPMLO · Traditional | Galix Biomedical Instrumentation, Inc. | 03/15/2001SE |
| K003940 | 2010 Plus Holter for WindowsMLO · Special | Agilent Technologies | 02/08/2001SE |
| K003763 | 2010 Plus Holter for WindowsMLO · Special | Agilent Technologies | 01/05/2001SE |
| K993788 | R.Test EvolutionMLO · Traditional | Novacor Div. | 08/04/2000SE |
| K992197 | Modification to Zymed Holter 2000MLO · Special | Zymed Medical Instrumentation | 07/28/1999SE |
| K990170 | Holter 2000MLO · Special | Zymed Medical Instrumentation | 04/13/1999SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0323-2025 Class II | Hillrom Welch Allyn Vision Express Holter Analysis System; ElectrocardiographThere is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system… | Baxter Healthcare Corporation | 10/11/2024Open, Classified |
| Z-0320-2025 Class II | Hillrom Welch Allyn HScribe Holter System; ambulatory monitoringThere is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system… | Baxter Healthcare Corporation | 10/11/2024Open, Classified |