FDA 510(k)

Emory Cardiac Toolbox 4.3

K-Number: K223422 · 2023-03-30

Decision Date2023-03-30

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Emory Cardiac Toolbox 4.3 is a medical device manufactured by Syntermed. It received FDA 510(k) clearance on 2023-03-30 under approval number K223422. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emory Cardiac Toolbox 4.3?

Emory Cardiac Toolbox 4.3 is a medical device that received FDA 510(k) clearance on 2023-03-30. It is manufactured by Syntermed. The 510(k) number is K223422.

When was Emory Cardiac Toolbox 4.3 approved by the FDA?

Emory Cardiac Toolbox 4.3 received FDA 510(k) clearance on 2023-03-30, under approval number K223422.

What company makes Emory Cardiac Toolbox 4.3?

Emory Cardiac Toolbox 4.3 is manufactured by Syntermed.

What is the FDA product code for Emory Cardiac Toolbox 4.3?

The FDA product code for Emory Cardiac Toolbox 4.3 is KPS.

Other Devices by Syntermed

K180077NeuroQ 3.8

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Official Source

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