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 the device name listed in this FDA 510(k) record. The listed applicant is Syntermed. It received FDA 510(k) clearance on 2023-03-30 under 510(k) 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. The listed applicant is Syntermed. The 510(k) number is K223422.

When did Emory Cardiac Toolbox 4.3 receive FDA 510(k) clearance?

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

Who is the listed applicant for Emory Cardiac Toolbox 4.3?

The FDA 510(k) record lists Syntermed as the applicant. This does not by itself establish the device manufacturer.

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 records listing Syntermed as applicant

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.

K180077NeuroQ 3.8

Related Devices (Code: KPS)

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.