K110525

Substantially Equivalent

VITALOGRAPH MODEL 7100 - VITALOJAK

Applicant: Vitalograph (Ireland) , Ltd.
Product code: DSH
Advisory panel: Cardiovascular
Date received: 2011-02-23
Decision date: 2011-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ennis, Co. Clare, IE

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.