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K Number
K252360

Validate with FDA (Live)

Device Name
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Manufacturer
Anumana, Inc.
Date Cleared
2026-03-28

(242 days)

Product Code
SAT
Regulation Number
870.2380
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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N/A