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Ivy Biomedical Systems, Inc.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories3
Latest FDA decision2024-09-13
TypeNumberDevice NameCodeDateActions
510(k) K240087 RT Carbon ECG LeadsDSA2024-09-13 View
510(k) K202138 Cardiac Trigger MonitorDRT2021-05-14 View
510(k) K203653 MRI PPG Patient CableLNH2021-03-02 View
510(k) K192852 MRI ECG Patient CableLNH2020-03-28 View
510(k) K171778 MR Wireless Gating System, Model WGS-100LNH2018-03-14 View
510(k) K170828 Cardiac Trigger MonitorDRT2017-05-17 View
510(k) K151781 Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization MonitorDRT2016-05-27 View
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