Low Ejection Fraction AI-ECG Algorithm— 510(k) K232699

Substantially Equivalent

Anumana, Inc.

FDA 510(k) clearance K232699 for Low Ejection Fraction AI-ECG Algorithm, Substantially Equivalent on 2023-09-28. Applicant: Anumana, Inc..

Clearance details

Applicant: Anumana, Inc.
Product code: Code QYE
Advisory panel: Cardiovascular
Date received: 2023-09-05
Decision date: 2023-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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