VITALOGRAPH MODEL 7100 - VITALOJAK— 510(k) K110525

Name: FDA 510(k) clearance K110525
Creator: U.S. Food and Drug Administration
Published: 2011-11-23

Substantially Equivalent

Vitalograph (Ireland) , Ltd.

FDA 510(k) clearance K110525 for VITALOGRAPH MODEL 7100 - VITALOJAK, Substantially Equivalent on 2011-11-23. Applicant: Vitalograph (Ireland) , Ltd.. Device class: 2.

Clearance details

Applicant: Vitalograph (Ireland) , Ltd.
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2011-02-23
Decision date: 2011-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ennis, Co. Clare, IE

Download summary PDF View on FDA.gov ↗

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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.