FDA 510(k) Application Details - K250119

Device Classification Name	More FDA Info for this Device
510(K) Number	K250119
Device Name	Tempus ECG-Low EF
Applicant	Tempus AI, Inc. 600 W Chicago Ave Suite #510 Chicago, IL 60654 US Other 510(k) Applications for this Company
Contact	Alain Silk Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2025
Decision Date	07/15/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review