K250119

Substantially Equivalent

Tempus ECG-Low EF

Applicant: Tempus AI, Inc.
Product code: QYE
Advisory panel: Cardiovascular
Date received: 2025-01-16
Decision date: 2025-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.