LOS

Product Code: LOS


Pre-market Notifications for LOS

K090895EKG-PLUS II SOFTWAREBIONET CO., LTD.
K083749CARDIOVIEW32 REVIEW MODULEQRS DIAGNOSTIC, LLC.
K073376PHILIPS ECG ALGORITHMPHILIPS MEDICAL SYSTEMS
K023034CARDIOTOUCH-3000BIONET COMPANY LTD
K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPHBIONET COMPANY LTD
K993616CARDIO-CARD INTERPRETATION SYSTEM INASIFF ASSOC., INC.
K991735MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHSGENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K991014CASE 8000 EXERCISE TESTING SYSTEMGENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K990266MICROMEDICAL 12 LEAD SIMULTANEOUS CABLEMICROMEDICAL INDUSTRIES, LTD.
K990031NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIESNIHON KOHDEN AMERICA, INC.
K984504NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIESNIHON KOHDEN AMERICA, INC.
K984465OXYCONALPHA WITH OPTION ECGERICH JAEGER B.V.
K981265PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENAHEWLETT-PACKARD CO.
K981066FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPHFUKUDA DENSHI USA, INC.
K981024QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM)MARQUETTE MEDICAL SYSTEMS, INC.

Maude Adverse Events

ELI 280MORTARA INSTRUMENT, INC.2017-10-11
BURDICK ECLIPSE PREMIERCARDIAC SCIENCE CORPORATION2013-09-04
BURDICK ECLIPSE PREMIERCARDIAC SCIENCE CORPORATION2012-07-12
BURDICK ECLIPSE PREMIERCARDIAC SCIENCE CORPORATION2012-06-28
EAGLE 4000GE HEALTHCARE2012-04-18
BURDICK ECLIPSE PREMIERCARDIAC SCIENCE CORPORATION2012-03-15
CARDIOCARE 2000BIONET AMERICA INC.2012-01-30
CARDIOCARE 2000BIONET AMERICA INC.2012-01-30
MAC 800GE MEDICAL SYSTEMS CHINA CO., LTD.2011-12-22
EAGLE 4000 PATIENT MONITORGE HEALTHCARE2011-08-01
DASH 2000CRITIKON DE MEXICO S. DE R.L. DE C.V.2011-07-01
EAGLE 4000 PATIENT MONITORGE HEALTHCARE2011-06-15
MICROSMARTGE HEALTHCARE2011-04-14
CARDIOCARE2000BIONET CO., LTD.2011-03-20
MAC 5500WIPRO GE HEALTHCARE PRIVATE LTD.2011-01-04
MAC 1200WIPRO GE HEALTHCARE PRIVATE LTD2010-11-17
SPACELABS ULTRAVIEW SL COMMAND MODULESPACELABS HEALTHCARE2010-09-04
LIFEPAK 11 DIAGNOSTIC CARDIAC MONITORPHYSIO-CONTROL, INC.2010-06-04
ELI 200 INTERPRETIVE ELECTROCARDIOGRAPH MACHINEMORTARA INSTRUMENTS2010-05-19
CASE P2 EKG STRESS SYSTEMGE MEDICAL SYSTEMS2008-12-09
EAGLE 4000GE HEALTHCARE2008-08-13
BURDICK ECLIPSE PREMIERCARDIAC SCIENCE CORPORATION2008-06-06
CARDIOSOFT / CASE CARDIAC TESTING SYSTEMGE HEALTHCARE2007-05-03
MAC ELECTROCARDIOGRAPH*2006-12-22
MAC ELECTROCARDIOGRAPH*2006-12-22
CARDIOCARE TELETRACE 9431MEDTRONIC, INC.2006-01-10
CASE 8000GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES2003-12-31
CASE 8000 EXERCISE TESTING MACHINE (EKG)GE MEDICAL SYSTEMS TECHNOLOGIES2003-12-03
CASE 8000 EXERCISE TESTING MACHINE (EKG)GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES2003-12-03
MAC ELECTROCARDIOGRAPHGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES2003-11-17
MAC ELECTROCARDIOGRAPHGE MECICAL SYSTEMS INFORMATION TECHNOLOGIES2003-06-10
GE/MARQUETTE MAC 5000GE MEDICAL SYSTEMS INFO TECHNOLOGIES2003-04-07
MAC ELECTROCARDIOGRAPHGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES2003-02-27
DUAL ECG MODULESPACELABS, INC1992-07-30
ECG MONITORBIOMEDICAL SYSTEMS, INC. (BILL DRISCOLL)1992-02-19

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