K250091

Substantially Equivalent

KOROT Blood Pressure Monitor (KOROT P3 Accurate)

Applicant: Korot Co., Ltd.
Product code: DXN
Advisory panel: Cardiovascular
Date received: 2025-01-14
Decision date: 2025-03-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Cheonan, KR

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.