K990112

Substantially Equivalent

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610

Applicant: Maersk Medical A/S
Product code: DRX
Advisory panel: Cardiovascular
Date received: 1999-01-13
Decision date: 1999-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.