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 Aug 26, 2009
EKG-PLUS II SOFTWARE
K090895
Bionet Co., Ltd.
Cardiovascular · 149d
Cleared Mar 10, 2009
CARDIOVIEW32 REVIEW MODULE
K083749
Qrs Diagnostic, LLC
Cardiovascular · 83d
Cleared Apr 11, 2008
PHILIPS ECG ALGORITHM
K073376
Philips Medical Systems
Cardiovascular · 130d
Cleared Nov 14, 2002
CARDIOTOUCH-3000
K023034
Bionet Company, Ltd.
Cardiovascular · 63d
Cleared Nov 21, 2001
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
K011328
Bionet Company, Ltd.
Cardiovascular · 204d
Cleared Apr 10, 2000
CARDIO-CARD INTERPRETATION SYSTEM I
K993616
Nasiff Assoc., Inc.
Cardiovascular · 167d
Cleared Oct 27, 1999
OXYCONALPHA WITH OPTION ECG
K984465
Erich Jaeger B.V.
Cardiovascular · 315d
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 Feb 02, 1999
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
K990266
Micromedical Industries, Ltd.
Cardiovascular · 5d
Cleared Oct 06, 1998
QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM)
K981024
Marquette Medical Systems, Inc.
Cardiovascular · 201d
Cleared Sep 08, 1998
CARDIOVIEW 3000 SOFTWARE
K974352
Micromedical, Inc.
Cardiovascular · 293d
Cleared Aug 31, 1998
FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH
K981066
Fukuda Denshi USA, Inc.
Cardiovascular · 160d
Cleared Aug 21, 1998
ELECTROCARDIOGRAPHS
K972587
Dr. Lee Co., Ltd.
Cardiovascular · 406d
Cleared Jul 07, 1998
PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM
K972255
Pulse Biomedical, Inc.
Cardiovascular · 385d
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 May 12, 1998
ARCHIMED 4210 AND 4220
K973922
Biosound Esaote, Inc.
Cardiovascular · 209d
Cleared May 07, 1998
MUSE CARDIOVASCULAR INFORMATION SYSTEM
K980495
Marquette Medical Systems, Inc.
Cardiovascular · 87d
Cleared Mar 12, 1998
CARDIOSMART ST
K973403
Marquette Medical Systems, Inc.
Cardiovascular · 184d
Cleared Feb 06, 1998
ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION
K974199
Marquette Medical Systems, Inc.
Cardiovascular · 88d
Cleared Dec 02, 1997
FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH
K971440
Fukuda Denshi USA, Inc.
Cardiovascular · 228d

About Product Code LOS - Regulatory Context