ELECTRODE, ELECTROCARDIOGRAPH— 510(k) K973727

Substantially Equivalent

Don Tay Industries

FDA 510(k) clearance K973727 for ELECTRODE, ELECTROCARDIOGRAPH, Substantially Equivalent on 1997-12-19. Applicant: Don Tay Industries.

Clearance details

Applicant: Don Tay Industries
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1997-09-30
Decision date: 1997-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Berlin, WI, US

Download summary PDF View on FDA.gov ↗

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.