MWJ — Electrocardiograph, Ambulatory (Without Analysis) Class II
FDA Device Classification
Classification Details
- Product Code
- MWJ
- Device Class
- Class II
- Regulation Number
- 870.2800
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K231424 | heartbeam | HeartBeam AIMIGo(TM) System | December 13, 2024 |
| K233864 | kestra medical technologies | ASSURE Wearable ECG | May 7, 2024 |
| K212317 | spacelabs healthcare | Eclipse MINI Model 98900 | November 7, 2022 |
| K222017 | biotricity | Biotres | July 28, 2022 |
| K210758 | medicalgorithmics | Q Patch | June 2, 2022 |
| K211709 | biotricity | Biotres | January 19, 2022 |
| K211651 | spacelabs healthcare | Eclipse PRO | November 22, 2021 |
| K173156 | sensydia | Integrated CardioRespiratory System | June 8, 2018 |
| K161062 | norav medical | NR Recorder | June 13, 2016 |
| K152626 | mortara instrument | H3+ Holter Recorder | February 26, 2016 |
| K142424 | north east monitoring | DR300 HOLTER MONITOR | November 25, 2014 |
| K133014 | diagnostic monitoring software | DMS 300-2W HOLTER ECG RECORDER | May 19, 2014 |
| K130294 | braemar manufacturing | BRAEMAR CARDIOKEY HOLTER RECORDER | October 16, 2013 |
| K130785 | getemed medizin- und informationstechnik | SEER 1000 | July 26, 2013 |
| K122272 | getemed medizin- und informationstechnik | CARDIOMEM | March 28, 2013 |
| K112573 | platinum team co | EZSLEEP SLEEP QUALITY RECORDER | March 22, 2012 |
| K112601 | intricon datrix corporation | INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER | November 9, 2011 |
| K101969 | exelys | MH1 MICROHOLTER RECORDER | February 4, 2011 |
| K101024 | suzuken co | KENZ CARDY302 MAX | January 6, 2011 |
| K102723 | memtec | MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS | December 9, 2010 |