MLO · Electrocardiograph, Ambulatory, With Analysis Algorithm
Cardiovascular · 21 CFR 870.2800 · Class 2
Overview
| Product Code | MLO |
|---|---|
| Device Name | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Regulation | 21 CFR 870.2800 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241890 | Philips Holter Analysis System | Philips Medizin Systeme Böblingen GmbH | Mar 21, 2025 | SESE |
| K240794 | Frontier X Plus | Fourth Frontier Technologies Pvt, Ltd. | Nov 8, 2024 | SESE |
| K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | Sep 2, 2020 | SESE |
| K193177 | CER-S | Cardiocalm | Aug 26, 2020 | SESE |
| K182030 | Faros Mobile | Bittium Biosignals , Ltd. | Nov 8, 2018 | SESE |
| K140847 | CARDIOSPY ECG HOLTER SYSTEMS | Labtech Kft. | Dec 5, 2014 | SESE |
| K131897 | CV3000 HOLTER ANALYSIS SYSTEM | Vales & Hills Biomedical Tech. , Ltd. | Nov 26, 2013 | SESE |
| K130660 | AUDICOR CPAM WITH SDB (SINGLE SENSOR) | Inovise Medical, Inc. | Oct 11, 2013 | SESE |
| K120462 | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) | Inovise Medical, Inc. | Sep 20, 2012 | SESE |
| K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | Norav Medical Corp. | Nov 10, 2011 | SESE |
| K110569 | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) | Inovise Medical, Inc. | Oct 24, 2011 | SESE |
| K101273 | DYNAMIC ECG SYSTEM MODEL TLC5000 | Contec Medical System Co., Ltd. | Sep 30, 2011 | SESE |
| K092853 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM | Galix Biomedical Instrumentation, Inc. | Jul 9, 2010 | SESE |
| K063339 | MEDICK MHM200 PERSONAL HEART MONITOR | Medick Healthcare , Ltd. | Jun 29, 2007 | SESE |
| K062088 | PREMIER 11 HOLTER | Diagnostic Monitoring Software | Aug 25, 2006 | SESE |
| K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | Global Instrumentation, LLC | Sep 26, 2005 | SESE |
| K042782 | SEER MC | Ge Medical Systems Information Technologies | Sep 2, 2005 | SESE |
| K043454 | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 | Medicomp, Inc. | Mar 24, 2005 | SESE |
| K042108 | VISTA PLUS | Novacor | Jan 19, 2005 | SESE |
| K040753 | R-TEST EVOLUTION 3 | Novacor | Jun 10, 2004 | SESE |
Top Applicants
- Agilent Technologies — 3 clearances
- Inovise Medical, Inc. — 3 clearances
- Galix Biomedical Instrumentation, Inc. — 2 clearances
- Novacor — 2 clearances
- Zymed Medical Instrumentation — 2 clearances
