mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)— 510(k) K253384
Substantially EquivalentSeers Technology Co., Ltd.
FDA 510(k) clearance K253384 for mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7), Substantially Equivalent on 2026-06-25. Applicant: Seers Technology Co., Ltd.. Device class: 2.
Summary
Seers Technology's mobiCARE Cardiac Monitoring System comes in four models: mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, and mobiCARE-MC200ML7. It's filed under MWJ, ambulatory electrocardiographs without analysis, and the record doesn't say how the models differ.
Class II, 21 CFR 870.2800. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Seers filed from Pyeongtaek-Si, South Korea. Review took 268 calendar days (September 30, 2025 to June 25, 2026).
Clearance details
- Applicant
- Seers Technology Co., Ltd.
- Product code
- Product code MWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pyeongtaek-Si, KR
Recent devices under product code MWJ
view allMore clearances from Seers Technology Co., Ltd.
view allAdverse events under product code MWJ
product code MWJ- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.