OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3— 510(k) K061822

Substantially Equivalent

Omron Healthcare, Inc.

FDA 510(k) clearance K061822 for OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3, Substantially Equivalent on 2006-08-02. Applicant: Omron Healthcare, Inc..

Clearance details

Applicant: Omron Healthcare, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2006-06-28
Decision date: 2006-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Bonita Springs, FL, US

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.