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Anumana, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories5
Latest FDA decision2026-06-15
TypeNumberDevice NameCodeDateActions
510(k) K260300 WatchMate SoftwareQIH2026-06-15 View
510(k) K253801 ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)SHP2026-04-07 View
510(k) K252360 ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)SAT2026-03-28 View
510(k) K250652 ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)QYE2025-07-28 View
510(k) K233160 NeuTrace EP Mapping System v.2.1DQK2023-11-25 View
510(k) K232699 Low Ejection Fraction AI-ECG AlgorithmQYE2023-09-28 View
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