Upper Arm Electronic Blood Pressure Monitor— 510(k) K202372

Substantially Equivalent

Conmo Electronic Company Limited

FDA 510(k) clearance K202372 for Upper Arm Electronic Blood Pressure Monitor, Substantially Equivalent on 2020-12-30. Applicant: Conmo Electronic Company Limited.

Clearance details

Applicant: Conmo Electronic Company Limited
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2020-08-19
Decision date: 2020-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen City, CN

Download summary PDF View on FDA.gov ↗

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.