Tempus ECG-AF
K-Number: K233549 · 2024-06-21
ApplicantTempus AI, Inc.
Decision Date2024-06-21
Product CodeSBQ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Tempus ECG-AF is a medical device manufactured by Tempus AI, Inc.. It received FDA 510(k) clearance on 2024-06-21 under approval number K233549. The device is classified under product code SBQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tempus ECG-AF?
Tempus ECG-AF is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Tempus AI, Inc.. The 510(k) number is K233549.
When was Tempus ECG-AF approved by the FDA?
Tempus ECG-AF received FDA 510(k) clearance on 2024-06-21, under approval number K233549.
What company makes Tempus ECG-AF?
Tempus ECG-AF is manufactured by Tempus AI, Inc..
What is the FDA product code for Tempus ECG-AF?
The FDA product code for Tempus ECG-AF is SBQ.
Other Devices by Tempus AI, Inc.
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.