ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC.— 510(k) K903555

Substantially Equivalent

Jason Marketing Co.

FDA 510(k) clearance K903555 for ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC., Substantially Equivalent on 1990-11-05. Applicant: Jason Marketing Co..

Clearance details

Applicant: Jason Marketing Co.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1990-08-07
Decision date: 1990-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington Beach, CA, 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.