FDA 510(k)

ECG-less Cardiac

K-Number: K233750 · 2024-04-02

Decision Date2024-04-02

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ECG-less Cardiac is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2024-04-02 under approval number K233750. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG-less Cardiac?

ECG-less Cardiac is a medical device that received FDA 510(k) clearance on 2024-04-02. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K233750.

When was ECG-less Cardiac approved by the FDA?

ECG-less Cardiac received FDA 510(k) clearance on 2024-04-02, under approval number K233750.

What company makes ECG-less Cardiac?

ECG-less Cardiac is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for ECG-less Cardiac?

The FDA product code for ECG-less Cardiac is JAK.

Other Devices by Ge Medical Systems, LLC

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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.