FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217— 510(k) K092061

Substantially Equivalent

Genexel Medical Instrument, Inc.

FDA 510(k) clearance K092061 for FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217, Substantially Equivalent on 2010-03-26. Applicant: Genexel Medical Instrument, Inc..

Clearance details

Applicant: Genexel Medical Instrument, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2009-07-08
Decision date: 2010-03-26
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.