VitaloJAK Clinic (Model 7100)— 510(k) K253293

Substantially Equivalent

Vitalograph , Ltd.

FDA 510(k) clearance K253293 for VitaloJAK Clinic (Model 7100), Substantially Equivalent on 2025-12-03. Applicant: Vitalograph , Ltd..

Clearance details

Applicant: Vitalograph , Ltd.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2025-09-29
Decision date: 2025-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Ennis Co. Clare, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.