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-staging.innolitics.com/productcode/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 64)

Showing 20 most recent of 64 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K254119](/device/K254119.md) | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) | Shenzhen Xinyan Medical Technology Co.,ltd. | Sep 11, 2026 | SESE |
| [K253529](/device/K253529.md) | Peerbridge COR MDx (Cor MDx) | Peerbridge Health, Inc. | Sep 4, 2026 | SESE |
| [K253562](/device/K253562.md) | medilogFD | Schiller AG | Aug 14, 2026 | SESE |
| [K253384](/device/K253384.md) | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) | Seers Technology Co., Ltd. | Jun 25, 2026 | SESE |
| [K252839](/device/K252839.md) | ZywieZ3 Sensor & Adhesive | Zywie, Inc. | Jun 18, 2026 | SESE |
| [K231424](/device/K231424.md) | HeartBeam AIMIGo(TM) System | Heartbeam, Inc. | Dec 13, 2024 | SESE |
| [K233864](/device/K233864.md) | ASSURE Wearable ECG | Kestra Medical Technologies, Inc. | May 7, 2024 | SESE |
| [K212317](/device/K212317.md) | Eclipse MINI Model 98900 | Spacelabs Healthcare, Ltd. | Nov 7, 2022 | SESE |
| [K222017](/device/K222017.md) | Biotres | Biotricity | Jul 28, 2022 | SESE |
| [K210758](/device/K210758.md) | Q Patch | Medicalgorithmics S.A. | Jun 2, 2022 | SESE |
| [K211709](/device/K211709.md) | Biotres | Biotricity | Jan 19, 2022 | SESE |
| [K211651](/device/K211651.md) | Eclipse PRO | Spacelabs Healthcare, Ltd. | Nov 22, 2021 | SESE |
| [K173156](/device/K173156.md) | Integrated CardioRespiratory System | Sensydia, Inc. | Jun 8, 2018 | SESE |
| [K161062](/device/K161062.md) | NR Recorder | Norav Medical GmbH | Jun 13, 2016 | SESE |
| [K152626](/device/K152626.md) | H3+ Holter Recorder | Mortara Instrument, Inc. | Feb 26, 2016 | SESE |
| [K142424](/device/K142424.md) | DR300 HOLTER MONITOR | North East Monitoring, Inc. | Nov 25, 2014 | SESE |
| [K133014](/device/K133014.md) | DMS 300-2W HOLTER ECG RECORDER | Diagnostic Monitoring Software | May 19, 2014 | SESE |
| [K130294](/device/K130294.md) | BRAEMAR CARDIOKEY HOLTER RECORDER | Braemar Manufacturing, LLC | Oct 16, 2013 | SESE |
| [K130785](/device/K130785.md) | SEER 1000 | Getemed Medizin- Und Informationstechnik AG | Jul 26, 2013 | SESE |
| [K122272](/device/K122272.md) | CARDIOMEM | Getemed Medizin- Und Informationstechnik AG | Mar 28, 2013 | 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-staging.innolitics.com/productcode/MWJ](https://fda-staging.innolitics.com/productcode/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