510(k) K162092— Evolv Model BP7000 Upper Arm Blood Pressure Monitor

Substantially Equivalent

Omron Healthcare, Inc.

Clearance details

Applicant: Omron Healthcare, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2016-07-28
Decision date: 2016-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, US

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.