K884983

Substantially Equivalent

M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55

Applicant: S & W Medico Teknik
Product code: DRX
Advisory panel: Cardiovascular
Date received: 1988-11-29
Decision date: 1989-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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.