CARDIAX— 510(k) K924544

Name: FDA 510(k) clearance K924544
Creator: U.S. Food and Drug Administration
Published: 1993-07-29

Substantially Equivalent

Fairlake Marketing Group, Inc.

FDA 510(k) clearance K924544 for CARDIAX, Substantially Equivalent on 1993-07-29. Applicant: Fairlake Marketing Group, Inc.. Device class: 2.

Clearance details

Applicant: Fairlake Marketing Group, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1992-09-08
Decision date: 1993-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

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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.