MWJ — Electrocardiograph, Ambulatory (Without Analysis) Class II
FDA product code MWJ covers "Electrocardiograph, Ambulatory (Without Analysis)", a Class II medical device regulated under 21 CFR 870.2800. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K254119 | shenzhen xinyan medical technology co | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); | September 11, 2026 |
| K253529 | peerbridge health | Peerbridge COR MDx (Cor MDx) | September 4, 2026 |
| K253562 | schiller | medilogFD | August 14, 2026 |
| K253384 | seers technology co | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE- | June 25, 2026 |
| K252839 | zywie | ZywieZ3 Sensor & Adhesive | June 18, 2026 |
| 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 |