Anumana, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)April 7, 2026
K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)March 28, 2026
K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)July 28, 2025
K233160NeuTrace EP Mapping System v.2.1November 25, 2023
K232699Low Ejection Fraction AI-ECG AlgorithmSeptember 28, 2023