Pursuant Health Kiosk (G1.D5)— 510(k) K230996

Substantially Equivalent

Pursuant Health

FDA 510(k) clearance K230996 for Pursuant Health Kiosk (G1.D5), Substantially Equivalent on 2024-01-04. Applicant: Pursuant Health.

Clearance details

Applicant: Pursuant Health
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2023-04-07
Decision date: 2024-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, 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.