MWJ · Electrocardiograph, Ambulatory (Without Analysis)
Cardiovascular · 21 CFR 870.2800 · Class 2
Overview
| Product Code | MWJ |
|---|---|
| Device Name | Electrocardiograph, Ambulatory (Without Analysis) |
| 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 59)
Showing 20 most recent of 59 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231424 | HeartBeam AIMIGo(TM) System | Heartbeam, Inc. | Dec 13, 2024 | SESE |
| K233864 | ASSURE Wearable ECG | Kestra Medical Technologies, Inc. | May 7, 2024 | SESE |
| K212317 | Eclipse MINI Model 98900 | Spacelabs Healthcare, Ltd. | Nov 7, 2022 | SESE |
| K222017 | Biotres | Biotricity | Jul 28, 2022 | SESE |
| K210758 | Q Patch | Medicalgorithmics S.A. | Jun 2, 2022 | SESE |
| K211709 | Biotres | Biotricity | Jan 19, 2022 | SESE |
| K211651 | Eclipse PRO | Spacelabs Healthcare, Ltd. | Nov 22, 2021 | SESE |
| K173156 | Integrated CardioRespiratory System | Sensydia, Inc. | Jun 8, 2018 | SESE |
| K161062 | NR Recorder | Norav Medical GmbH | Jun 13, 2016 | SESE |
| K152626 | H3+ Holter Recorder | Mortara Instrument, Inc. | Feb 26, 2016 | SESE |
| K142424 | DR300 HOLTER MONITOR | North East Monitoring, Inc. | Nov 25, 2014 | SESE |
| K133014 | DMS 300-2W HOLTER ECG RECORDER | Diagnostic Monitoring Software | May 19, 2014 | SESE |
| K130294 | BRAEMAR CARDIOKEY HOLTER RECORDER | Braemar Manufacturing, LLC | Oct 16, 2013 | SESE |
| K130785 | SEER 1000 | Getemed Medizin- Und Informationstechnik AG | Jul 26, 2013 | SESE |
| K122272 | CARDIOMEM | Getemed Medizin- Und Informationstechnik AG | Mar 28, 2013 | SESE |
| K112573 | EZSLEEP SLEEP QUALITY RECORDER | Platinum Team Co., Ltd. | Mar 22, 2012 | SESE |
| K112601 | INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER | Intricon Datrix Corporation | Nov 9, 2011 | SESE |
| K101969 | MH1 MICROHOLTER RECORDER | Exelys, LLC | Feb 4, 2011 | SESE |
| K101024 | KENZ CARDY302 MAX | Suzuken Co., Ltd. | Jan 6, 2011 | SESE |
| K102723 | 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
