FDA 510(k) Applications Submitted by IVY BIOMEDICAL SYSTEMS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K202138 07/31/2020 Cardiac Trigger Monitor Ivy Biomedical Systems, Inc.
K192852 10/03/2019 MRI ECG Patient Cable Ivy Biomedical Systems, Inc.
K203653 12/15/2020 MRI PPG Patient Cable Ivy Biomedical Systems, Inc.
K110987 04/08/2011 CARDIAC TRIGGER MONITOR IVY BIOMEDICAL SYSTEMS, INC.
K982255 06/26/1998 MODEL 2000 PULSE OXIMETER IVY BIOMEDICAL SYSTEMS, INC.
K091985 07/02/2009 UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE IVY BIOMEDICAL SYSTEMS, INC.
K023616 10/29/2002 PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) IVY BIOMEDICAL SYSTEMS, INC.
K955546 12/05/1995 PATIENT MONITOR MODEL 405P IVY BIOMEDICAL SYSTEMS, INC.
K964961 12/11/1996 MODEL 405T WITH ETCO2 OPTION IVY BIOMEDICAL SYSTEMS, INC.
K083854 12/24/2008 CARDIAC TRIGGER, MODEL: CTM300 IVY BIOMEDICAL SYSTEMS, INC.
K091787 06/17/2009 MODEL 6000 TWO PARAMETER BEDSIDE MONITOR IVY BIOMEDICAL SYSTEMS, INC.
K170828 03/20/2017 Cardiac Trigger Monitor Ivy Biomedical Systems, Inc.


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