Cardio-TriTest v6.5— 510(k) K182790

Substantially Equivalent

Cardio-Phoenix, Inc.

FDA 510(k) clearance K182790 for Cardio-TriTest v6.5, Substantially Equivalent on 2018-12-14. Applicant: Cardio-Phoenix, Inc..

Clearance details

Applicant: Cardio-Phoenix, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2018-10-01
Decision date: 2018-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Markham, CA

Download summary PDF View on FDA.gov ↗

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.