K253384
- 510(k) number
- K253384
- Device name
- mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)
- Applicant
- Seers Technology Co., Ltd. KR
- Product code
- MWJ — Electrocardiograph, Ambulatory (Without Analysis)
- Decision date
- 2026-06-25
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K253384.pdf
Official FDA record: K253384
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.