K842954

Substantially Equivalent

CARDIONOSTICS HOLTER DURA-LITE RECORDE

Applicant: Cardionostics, Inc.
Product code: DSH
Advisory panel: Cardiovascular
Date received: 1984-07-27
Decision date: 1984-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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.