FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750— 510(k) K071523

Substantially Equivalent

Genexel-Sein, Inc.

FDA 510(k) clearance K071523 for FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750, Substantially Equivalent on 2007-06-26. Applicant: Genexel-Sein, Inc..

Clearance details

Applicant: Genexel-Sein, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2007-06-04
Decision date: 2007-06-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Roswell, GA, 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.