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Opsens, Inc.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories2
Latest FDA decision2026-01-16
TypeNumberDevice NameCodeDateActions
510(k) K251367 OptoMonitor 3DXO2026-01-16 View
510(k) K241418 OptoMonitor 3DXO2025-02-12 View
510(k) K240864 PacePro WireDQX2024-05-24 View
510(k) K213854 SavvyWireDQX2022-09-14 View
510(k) K202943 OptoMonitor 3DXO2020-11-24 View
510(k) K193620 OptoMonitor 3DXO2020-06-18 View
510(k) K191907 OptoWire IIIDQX2020-01-02 View
510(k) K192340 OptoMonitorDXO2019-12-12 View
510(k) K161263 OptoMonitor IIDXO2016-09-13 View
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