ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)— 510(k) K253801

Substantially Equivalent

Anumana, Inc.

FDA 510(k) clearance K253801 for ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040), Substantially Equivalent on 2026-04-07. Applicant: Anumana, Inc..

Clearance details

Applicant: Anumana, Inc.
Product code: Code SHP
Advisory panel: Cardiovascular
Date received: 2025-11-28
Decision date: 2026-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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