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Tempus AI receives 510(k) Premarket Notification for Tempus ECG-AF

Tempus AI receives 510(k) Premarket Notification for Tempus ECG-AF

Tempus AI received a 510(k) Premarket Notification from the FDA to indicate that the Tempus ECG-AF device was judged “Substantially Equivalent,” according to a notice posted to the FDA site with a decision date of June 21.

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