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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 the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Phoenix, Inc.. It received FDA 510(k) clearance on 2018-12-14 under 510(k) 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. The listed applicant is Cardio-Phoenix, Inc.. The 510(k) number is K182790.

When did Cardio-TriTest v6.5 receive FDA 510(k) clearance?

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

Who is the listed applicant for Cardio-TriTest v6.5?

The FDA 510(k) record lists Cardio-Phoenix, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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