ECG MONITORING SYSTEM,— 510(k) K780404

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K780404 for ECG MONITORING SYSTEM,, Substantially Equivalent on 1978-03-28. Applicant: Quinton, Inc..

Clearance details

Applicant: Quinton, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1978-03-13
Decision date: 1978-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.