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Ivy Biomedical Systems, Inc.

FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27
Categories0
Latest FDA decision
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
510(k) K110987 CARDIAC TRIGGER MONITORDRT2011-07-22 View
510(k) K091787 MODEL 6000 TWO PARAMETER BEDSIDE MONITORDQA2009-10-09 View
510(k) K091985 UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULEDRT2009-07-24 View
510(k) K083854 CARDIAC TRIGGER, MODEL: CTM300DRT2009-02-13 View
510(k) K023616 PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)DRT2002-11-04 View
510(k) K982255 MODEL 2000 PULSE OXIMETERDQA1998-10-22 View
510(k) K964961 MODEL 405T WITH ETCO2 OPTIONCCK1997-05-14 View
510(k) K955546 PATIENT MONITOR MODEL 405PDPS1996-08-16 View
510(k) K945099 PARAMETERS MONITORESMHX1995-07-13 View
510(k) K912139 MODEL 704GWM1992-03-25 View
510(k) K904606 MODEL 405DPS1991-03-01 View
510(k) K901504 MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP.DQA1990-08-23 View
510(k) K884455 MODEL 702 ECG/RESPIRATION/TEMPERATUREDRT1989-03-09 View
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