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FDA 510(k) Applications Submitted by Francis Casey
FDA 510(k) Number
Submission Date
Device Name
Applicant
K002030
07/03/2000
OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
INVIVO RESEARCH, INC.
K172200
07/21/2017
3880 MRI Patient Monitoring System
Iradimed Corporation
K974581
12/08/1997
MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT
INVIVO RESEARCH, INC.
K090087
01/13/2009
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
IRADIMED CORPORATION
K050301
02/08/2005
MRIDIUM 3850 MRI PUMP SYSTEM
IRADIMED CORPORATION
K950688
02/14/1995
OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM
SAFETY TEK CORP.
K971840
05/19/1997
OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM
INVIVO RESEARCH, INC.
K982132
06/17/1998
BLEASE 6200 ANAESTHESIA VENTILATOR
BLEASE MEDICAL EQUIPMENT LTD.
K982137
06/17/1998
BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
BLEASE MEDICAL EQUIPMENT LTD.
K002604
08/22/2000
CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
INVIVO RESEARCH, INC.
K924709
09/18/1992
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
AIR-SHIELDS, INC.
K955045
11/03/1995
OMNI-TRAK PATIENT MONITORING SYSTEM
INVIVO RESEARCH, INC.
K143369
11/25/2014
MRidium 3860+ MRI infusion Pump/ Monitoring System
IRADIMED CORPORATION
K180903
04/06/2018
3880 MRI Patient Monitoring System
Iradimed Corporation
K182900
10/16/2018
3880 MRI Patient Monitoring System
Iradimed Corporation
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