LOS

FDA Product Code LOS:

Leading manufacturers include Marquette Electronics, Inc., Hewlett-Packard Co. and Mortara Instrument, Inc..

83
Total
83
Cleared
221d
Avg days
1978
Since
83 devices
25–48 of 83
Cleared Jun 25, 1997
CARDIOVIT CS-200
K970879
Schiller America, Inc.
Cardiovascular · 107d
Cleared Feb 21, 1997
EAGLE 4000 PATIENT MONITOR
K964750
Marquette Electronics, Inc.
Cardiovascular · 87d
Cleared Jan 27, 1997
HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT
K962854
Cardio Control BV
Cardiovascular · 189d
Cleared Dec 10, 1996
MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS
K961223
Criticare Systems, Inc.
Cardiovascular · 256d
Cleared Nov 01, 1996
NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
K961272
Nihon Kohden America, Inc.
Cardiovascular · 213d
Cleared Jul 31, 1996
QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH
K961014
Quinton, Inc.
Cardiovascular · 140d
Cleared May 15, 1996
PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO
K954980
Hewlett-Packard Co.
Cardiovascular · 197d
Cleared Apr 23, 1996
ECLIPSE 4 ELECTROCARDIOGRAPH
K946281
Burdick, Inc.
Cardiovascular · 483d
Cleared Apr 04, 1996
CARDIOSOFT/CARDIOSYS
K951130
Marquette Electronics, Inc.
Cardiovascular · 388d
Cleared Jan 04, 1996
HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE PREDICITIVE INSTRUMENT (ACI-TIPT)
K951978
Hewlett-Packard Co.
Cardiovascular · 252d
Cleared Dec 19, 1995
CARDIOVIT AT-1C, AT-2C
K953396
Schiller America, Inc.
Cardiovascular · 152d
Cleared Aug 24, 1995
CENTRA HEART STATION
K935589
Marquette Electronics, Inc.
Cardiovascular · 644d
Cleared May 26, 1995
ECG FAX MODEM
K941282
Hewlett-Packard Co.
Cardiovascular · 441d
Cleared May 19, 1995
CARDIOVIT AT-5C
K941462
Schiller America, Inc.
Cardiovascular · 421d
Cleared May 17, 1995
ECLIPSE 4 ELECTROCARDIOGRAPH
K943959
Burdick, Inc.
Cardiovascular · 275d
Cleared Jul 26, 1994
HP M177XA CARDIOGRAPHS
K935772
Hewlett-Packard Co.
Cardiovascular · 235d
Cleared Apr 15, 1994
MODEL ELI 300 ELECTROCARDIOGRAPH
K933143
Mortara Instrument, Inc.
Cardiovascular · 291d
Cleared Mar 01, 1994
CARDIOFAX Q ECG-8420A
K922394
Nihon Kohden America, Inc.
Cardiovascular · 650d
Cleared Dec 06, 1993
SPACE LABS MODEL 90560
K923788
Spacelabs, Inc.
Cardiovascular · 496d
Cleared Nov 01, 1993
CARDIO PERFECT, CARDIO PERFECT MD
K922898
Cardio Control BV
Cardiovascular · 503d
Cleared May 07, 1993
MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITION
K921669
Marquette Electronics, Inc.
Cardiovascular · 394d
Cleared Apr 21, 1993
SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM
K922221
Del Mar Avionics
Cardiovascular · 344d
Cleared Nov 10, 1992
MORTARA INSTRUMENT ODEL ELI 50I
K915730
Mortara Instrument, Inc.
Cardiovascular · 326d
Cleared Nov 03, 1992
CARDIOVIT CS-100
K914970
Schiller America, Inc.
Cardiovascular · 364d