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FDA 510(k)

CardioSTAT® ECG Test Solution

K-Number: K223049 · 2023-03-22

ApplicantIcentia, Inc.
Decision Date2023-03-22
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardioSTAT® ECG Test Solution is a medical device manufactured by Icentia, Inc.. It received FDA 510(k) clearance on 2023-03-22 under approval number K223049. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CardioSTAT® ECG Test Solution?

CardioSTAT® ECG Test Solution is a medical device that received FDA 510(k) clearance on 2023-03-22. It is manufactured by Icentia, Inc.. The 510(k) number is K223049.

When was CardioSTAT® ECG Test Solution approved by the FDA?

CardioSTAT® ECG Test Solution received FDA 510(k) clearance on 2023-03-22, under approval number K223049.

What company makes CardioSTAT® ECG Test Solution?

CardioSTAT® ECG Test Solution is manufactured by Icentia, Inc..

What is the FDA product code for CardioSTAT® ECG Test Solution?

The FDA product code for CardioSTAT® ECG Test Solution is DSH.

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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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