HealthChek Network Health Station— 510(k) K152107

Substantially Equivalent

Healthchek Network, LLC

FDA 510(k) clearance K152107 for HealthChek Network Health Station, Substantially Equivalent on 2016-04-12. Applicant: Healthchek Network, LLC.

Clearance details

Applicant: Healthchek Network, LLC
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2015-07-29
Decision date: 2016-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Charles, LA, 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.