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FDA 510(k)

Cardio-TriTest v6.5

K-Number: K182790 · 2018-12-14

ApplicantCardio-Phoenix, Inc.
Decision Date2018-12-14
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cardio-TriTest v6.5 is a medical device manufactured by Cardio-Phoenix, Inc.. It received FDA 510(k) clearance on 2018-12-14 under approval number K182790. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardio-TriTest v6.5?

Cardio-TriTest v6.5 is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by Cardio-Phoenix, Inc.. The 510(k) number is K182790.

When was Cardio-TriTest v6.5 approved by the FDA?

Cardio-TriTest v6.5 received FDA 510(k) clearance on 2018-12-14, under approval number K182790.

What company makes Cardio-TriTest v6.5?

Cardio-TriTest v6.5 is manufactured by Cardio-Phoenix, Inc..

What is the FDA product code for Cardio-TriTest v6.5?

The FDA product code for Cardio-TriTest v6.5 is DPS.

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Official Source

View on FDA Database →

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