Medical Device Manufacturer · US , Geramantown , MD

Senseonics, Incorporated - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2024
2
Total
1
Cleared
1
Denied
FDA 510(k) Regulatory Record - Senseonics, Incorporated Chemistry ✕
2 devices
1-2 of 2
Cleared Sep 16, 2024
Eversense 365 Continuous Glucose Monitoring (CGM) System
K241335 · SBA
Chemistry · 126d
Not Cleared Apr 29, 2024
Eversense AP CGM System
DEN230052 · SBA
Chemistry · 264d
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