ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)— 510(k) K252360

Substantially Equivalent

Anumana, Inc.

FDA 510(k) clearance K252360 for ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020), Substantially Equivalent on 2026-03-28. Applicant: Anumana, Inc..

Clearance details

Applicant: Anumana, Inc.
Product code: Code SAT
Advisory panel: Cardiovascular
Date received: 2025-07-29
Decision date: 2026-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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