DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560— 510(k) K990113

Substantially Equivalent

Maersk Medical A/S

FDA 510(k) clearance K990113 for DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560, Substantially Equivalent on 1999-12-06. Applicant: Maersk Medical A/S.

Clearance details

Applicant: Maersk Medical A/S
Product code: 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

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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.