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

FDA 510(k) Cleared LOS Devices (Product Code LOS)

83 devices
1–24 of 83
Cleared Apr 11, 2008
PHILIPS ECG ALGORITHM
K073376
Philips Medical Systems
Cardiovascular · 130d
Cleared Oct 20, 1999
CASE 8000 EXERCISE TESTING SYSTEM
K991014
General Electric Medical Systems Information Techn
Cardiovascular · 208d
Cleared Aug 19, 1999
MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS
K991735
General Electric Medical Systems Information Techn
Cardiovascular · 90d
Cleared Apr 16, 1999
NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES
K990031
Nihon Kohden America, Inc.
Cardiovascular · 101d
Cleared Apr 15, 1999
NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES
K984504
Nihon Kohden America, Inc.
Cardiovascular · 118d
Cleared Aug 31, 1998
FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH
K981066
Fukuda Denshi USA, Inc.
Cardiovascular · 160d
Cleared Jun 23, 1998
PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA
K981265
Hewlett-Packard Co.
Cardiovascular · 77d
Cleared Jun 15, 1998
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT
K974087
Hewlett-Packard Co.
Cardiovascular · 229d
Cleared Dec 02, 1997
FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH
K971440
Fukuda Denshi USA, Inc.
Cardiovascular · 228d
Cleared Feb 21, 1997
EAGLE 4000 PATIENT MONITOR
K964750
Marquette Electronics, Inc.
Cardiovascular · 87d
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 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 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 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 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

About Product Code LOS - Regulatory Context