510(k) K003804— SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801

Substantially Equivalent

Niko Medical Products

Clearance details

Applicant: Niko Medical Products
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 2000-12-08
Decision date: 2001-08-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.