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FDA 510(k)

Universal SmartECG

K-Number: K173952 · 2018-08-28

ApplicantVectracor, Inc.
Decision Date2018-08-28
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Universal SmartECG is a medical device manufactured by Vectracor, Inc.. It received FDA 510(k) clearance on 2018-08-28 under approval number K173952. 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 Universal SmartECG?

Universal SmartECG is a medical device that received FDA 510(k) clearance on 2018-08-28. It is manufactured by Vectracor, Inc.. The 510(k) number is K173952.

When was Universal SmartECG approved by the FDA?

Universal SmartECG received FDA 510(k) clearance on 2018-08-28, under approval number K173952.

What company makes Universal SmartECG?

Universal SmartECG is manufactured by Vectracor, Inc..

What is the FDA product code for Universal SmartECG?

The FDA product code for Universal SmartECG is DPS.

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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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