Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2800](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2800) → MLO — Electrocardiograph, Ambulatory, With Analysis Algorithm # MLO · Electrocardiograph, Ambulatory, With Analysis Algorithm _Cardiovascular · 21 CFR 870.2800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO ## Overview - **Product Code:** MLO - **Device Name:** Electrocardiograph, Ambulatory, With Analysis Algorithm - **Regulation:** [21 CFR 870.2800](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2800) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## 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](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K241890.md) | Philips Holter Analysis System | Philips Medizin Systeme Böblingen GmbH | Mar 21, 2025 | SESE | | [K240794](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K240794.md) | Frontier X Plus | Fourth Frontier Technologies Pvt, Ltd. | Nov 8, 2024 | SESE | | [K200833](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K200833.md) | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | Sep 2, 2020 | SESE | | [K193177](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K193177.md) | CER-S | Cardiocalm | Aug 26, 2020 | SESE | | [K182030](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K182030.md) | Faros Mobile | Bittium Biosignals , Ltd. | Nov 8, 2018 | SESE | | [K140847](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K140847.md) | CARDIOSPY ECG HOLTER SYSTEMS | Labtech Kft. | Dec 5, 2014 | SESE | | [K131897](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K131897.md) | CV3000 HOLTER ANALYSIS SYSTEM | Vales & Hills Biomedical Tech. , Ltd. | Nov 26, 2013 | SESE | | [K130660](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K130660.md) | AUDICOR CPAM WITH SDB (SINGLE SENSOR) | Inovise Medical, Inc. | Oct 11, 2013 | SESE | | [K120462](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K120462.md) | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) | Inovise Medical, Inc. | Sep 20, 2012 | SESE | | [K111487](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K111487.md) | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | Norav Medical Corp. | Nov 10, 2011 | SESE | | [K110569](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K110569.md) | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) | Inovise Medical, Inc. | Oct 24, 2011 | SESE | | [K101273](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K101273.md) | DYNAMIC ECG SYSTEM MODEL TLC5000 | Contec Medical System Co., Ltd. | Sep 30, 2011 | SESE | | [K092853](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K092853.md) | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM | Galix Biomedical Instrumentation, Inc. | Jul 9, 2010 | SESE | | [K063339](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K063339.md) | MEDICK MHM200 PERSONAL HEART MONITOR | Medick Healthcare , Ltd. | Jun 29, 2007 | SESE | | [K062088](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K062088.md) | PREMIER 11 HOLTER | Diagnostic Monitoring Software | Aug 25, 2006 | SESE | | [K051730](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K051730.md) | MATRIX HOLTER SYSTEM, MODEL M12 | Global Instrumentation, LLC | Sep 26, 2005 | SESE | | [K042782](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K042782.md) | SEER MC | Ge Medical Systems Information Technologies | Sep 2, 2005 | SESE | | [K043454](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K043454.md) | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 | Medicomp, Inc. | Mar 24, 2005 | SESE | | [K042108](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K042108.md) | VISTA PLUS | Novacor | Jan 19, 2005 | SESE | | [K040753](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO/K040753.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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