Tempus ECG-Low EF— 510(k) K250119

Substantially Equivalent

Tempus AI, Inc.

FDA 510(k) clearance K250119 for Tempus ECG-Low EF, Substantially Equivalent on 2025-07-15. Applicant: Tempus AI, Inc..

Clearance details

Applicant: Tempus AI, Inc.
Product code: 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

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