CARDIAN III CR6A— 510(k) K864704

Substantially Equivalent

Cardiac Recorders, Ltd.

FDA 510(k) clearance K864704 for CARDIAN III CR6A, Substantially Equivalent on 1987-03-20. Applicant: Cardiac Recorders, Ltd..

Clearance details

Applicant: Cardiac Recorders, Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1986-12-02
Decision date: 1987-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.