CARDIOFAX ECG 6543— 510(k) K840274

Substantially Equivalent

Nihon Kohden America, Inc.

FDA 510(k) clearance K840274 for CARDIOFAX ECG 6543, Substantially Equivalent on 1984-04-17. Applicant: Nihon Kohden America, Inc..

Clearance details

Applicant: Nihon Kohden America, Inc.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1984-01-23
Decision date: 1984-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foothill, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.