Anumana, Inc.

Medical device manufacturer in Cambridge, MA.

6510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K260300WatchMate SoftwareQIH · Traditional 06/15/2026SE
K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)SHP · Traditional 04/07/2026SE
K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)SAT · Traditional 03/28/2026SE
K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)QYE · Traditional 07/28/2025SE
K233160NeuTrace EP Mapping System v.2.1DQK · Traditional 11/25/2023SE
K232699Low Ejection Fraction AI-ECG AlgorithmQYE · Traditional 09/28/2023SE