MWJ
- Product code
- MWJ
- Device name
- Electrocardiograph, Ambulatory (Without Analysis)
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2800
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 62 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253562 | 2026-08-14 | Schiller AG | medilogFD | |
| K253384 | 2026-06-25 | Seers Technology Co., Ltd. | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M,… | FDA |
| K252839 | 2026-06-18 | Zywie, Inc. | ZywieZ3 Sensor & Adhesive | FDA |
| K231424 | 2024-12-13 | Heartbeam, Inc. | HeartBeam AIMIGo(TM) System | FDA |
| K233864 | 2024-05-07 | Kestra Medical Technologies, Inc. | ASSURE Wearable ECG |
Official FDA classification page: MWJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).