Medical Device Manufacturer · US , Branford , CT

Ivy Biomedical Systems, Inc. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 1986
27
Total
27
Cleared
0
Denied

FDA 510(k) cleared devices by Ivy Biomedical Systems, Inc. Cardiovascular

20 devices
1-20 of 20
Cleared Sep 13, 2024
RT Carbon ECG Leads
K240087 · DSA
Cardiovascular · 246d
Cleared May 14, 2021
Cardiac Trigger Monitor
K202138 · DRT
Cardiovascular · 287d
Cleared Mar 28, 2020
MRI ECG Patient Cable
K192852 · LNH
Cardiovascular · 177d
Cleared May 17, 2017
Cardiac Trigger Monitor
K170828 · DRT
Cardiovascular · 58d
Cleared May 27, 2016
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
K151781 · DRT
Cardiovascular · 331d
Cleared Jul 22, 2011
CARDIAC TRIGGER MONITOR
K110987 · DRT
Cardiovascular · 105d
Cleared Jul 24, 2009
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
K091985 · DRT
Cardiovascular · 22d
Cleared Feb 13, 2009
CARDIAC TRIGGER, MODEL: CTM300
K083854 · DRT
Cardiovascular · 51d
Cleared Nov 04, 2002
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
K023616 · DRT
Cardiovascular · 6d
Cleared Aug 16, 1996
PATIENT MONITOR MODEL 405P
K955546 · DPS
Cardiovascular · 255d
Cleared Jul 13, 1995
PARAMETERS MONITORES
K945099 · MHX
Cardiovascular · 268d
Cleared Mar 01, 1991
MODEL 405
K904606 · DPS
Cardiovascular · 142d
Cleared Mar 09, 1989
MODEL 702 ECG/RESPIRATION/TEMPERATURE
K884455 · DRT
Cardiovascular · 136d
Cleared Feb 23, 1989
PATIENT MONITOR MODEL 701
K884096 · DRT
Cardiovascular · 148d
Cleared Feb 02, 1989
PATIENT MONITOR MODEL 703
K884662 · DPS
Cardiovascular · 87d
Cleared Aug 02, 1988
MODEL 700 PATIENT MONITOR
K882118 · DRS
Cardiovascular · 75d
Cleared Jul 28, 1988
MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR
K882188 · DXN
Cardiovascular · 65d
Cleared Mar 22, 1988
MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
K880066 · DRT
Cardiovascular · 71d
Cleared Aug 18, 1986
PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
K862647 · DSK
Cardiovascular · 38d
Cleared May 07, 1986
PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A
K854840 · DPS
Cardiovascular · 154d
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