Bardy Diagnostics, Inc.

Medical device manufacturer in Bellevue, WA.

7510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K233110Carnation Ambulatory MonitorDSH · Traditional 11/22/2023SE
K210036Carnation Ambulatory Monitor (CAM)DSH · Special 02/05/2021SE
K200870Carnation Ambulatory MonitorDSH · Special 05/01/2020SE
K192556Carnation Ambulatory MonitorDSH · Special 10/17/2019SE
K191471Carnation Ambulatory MonitorDSH · Special 08/30/2019SE
K191000Carnation Ambulatory MonitorDSH · Special 05/16/2019SE
K143067Carnation Ambulatory MonitorDSH · Traditional 12/22/2014SE