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) → MWJ — Electrocardiograph, Ambulatory (Without Analysis) # MWJ · Electrocardiograph, Ambulatory (Without Analysis) _Cardiovascular · 21 CFR 870.2800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ ## Overview - **Product Code:** MWJ - **Device Name:** Electrocardiograph, Ambulatory (Without Analysis) - **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 59) Showing 20 most recent of 59 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K231424](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K231424.md) | HeartBeam AIMIGo(TM) System | Heartbeam, Inc. | Dec 13, 2024 | SESE | | [K233864](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K233864.md) | ASSURE Wearable ECG | Kestra Medical Technologies, Inc. | May 7, 2024 | SESE | | [K212317](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K212317.md) | Eclipse MINI Model 98900 | Spacelabs Healthcare, Ltd. | Nov 7, 2022 | SESE | | [K222017](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K222017.md) | Biotres | Biotricity | Jul 28, 2022 | SESE | | [K210758](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K210758.md) | Q Patch | Medicalgorithmics S.A. | Jun 2, 2022 | SESE | | [K211709](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K211709.md) | Biotres | Biotricity | Jan 19, 2022 | SESE | | [K211651](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K211651.md) | Eclipse PRO | Spacelabs Healthcare, Ltd. | Nov 22, 2021 | SESE | | [K173156](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K173156.md) | Integrated CardioRespiratory System | Sensydia, Inc. | Jun 8, 2018 | SESE | | [K161062](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K161062.md) | NR Recorder | Norav Medical GmbH | Jun 13, 2016 | SESE | | [K152626](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K152626.md) | H3+ Holter Recorder | Mortara Instrument, Inc. | Feb 26, 2016 | SESE | | [K142424](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K142424.md) | DR300 HOLTER MONITOR | North East Monitoring, Inc. | Nov 25, 2014 | SESE | | [K133014](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K133014.md) | DMS 300-2W HOLTER ECG RECORDER | Diagnostic Monitoring Software | May 19, 2014 | SESE | | [K130294](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K130294.md) | BRAEMAR CARDIOKEY HOLTER RECORDER | Braemar Manufacturing, LLC | Oct 16, 2013 | SESE | | [K130785](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K130785.md) | SEER 1000 | Getemed Medizin- Und Informationstechnik AG | Jul 26, 2013 | SESE | | [K122272](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K122272.md) | CARDIOMEM | Getemed Medizin- Und Informationstechnik AG | Mar 28, 2013 | SESE | | [K112573](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K112573.md) | EZSLEEP SLEEP QUALITY RECORDER | Platinum Team Co., Ltd. | Mar 22, 2012 | SESE | | [K112601](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K112601.md) | INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER | Intricon Datrix Corporation | Nov 9, 2011 | SESE | | [K101969](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K101969.md) | MH1 MICROHOLTER RECORDER | Exelys, LLC | Feb 4, 2011 | SESE | | [K101024](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K101024.md) | KENZ CARDY302 MAX | Suzuken Co., Ltd. | Jan 6, 2011 | SESE | | [K102723](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K102723.md) | MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS | Memtec Corp. | Dec 9, 2010 | SESE | ## Top Applicants - North East Monitoring, Inc. — 5 clearances - Getemed Medizin- Und Informationstechnik AG — 4 clearances - Braemar Corp. — 3 clearances - Braemar, Inc. — 3 clearances - Mortara Instrument, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com