mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)— 510(k) K253384

Name: FDA 510(k) clearance K253384
Creator: U.S. Food and Drug Administration
Published: 2026-06-25

Substantially Equivalent

Seers 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.

Clearance details

Applicant: Seers Technology Co., Ltd.
Product code: Code MWJ
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2025-09-30
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek-Si, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.