ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)— 510(k) K250652

Substantially Equivalent

Anumana, Inc.

FDA 510(k) clearance K250652 for ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010), Substantially Equivalent on 2025-07-28. Applicant: Anumana, Inc..

Clearance details

Applicant: Anumana, Inc.
Product code: Code QYE
Advisory panel: Cardiovascular
Date received: 2025-03-04
Decision date: 2025-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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