ClearanceBrief
Product code LOS

LOS

0510(k)s in 12 months (83 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
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Top companies in LOS

Company510(k)sRecalls
Marquette Electronics, Inc.90
Hewlett-Packard Co.70
Mortara Instrument, Inc.60
Burdick Corp.50
Fukuda Denshi USA, Inc.40
Marquette Medical Systems, Inc.40
Nihon Kohden America, Inc.40
Schiller America, Inc.40
Siemens Burdick, Inc.40
Bionet Co., Ltd.30
Decided510(k)Device and applicantCode
Aug 26, 2009K090895EKG-PLUS II SOFTWARE
Bionet Co., Ltd., KR
LOS
Mar 10, 2009K083749CARDIOVIEW32 REVIEW MODULE
Qrs Diagnostic, LLC
LOS
Apr 11, 2008K073376PHILIPS ECG ALGORITHM
Philips Medical Systems
LOS
Nov 14, 2002K023034CARDIOTOUCH-3000
Bionet Company, Ltd.
LOS
Nov 21, 2001K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
Bionet Company, Ltd., KR
LOS
Apr 10, 2000K993616CARDIO-CARD INTERPRETATION SYSTEM I
Nasiff Assoc., Inc.
LOS
Oct 27, 1999K984465OXYCONALPHA WITH OPTION ECG
Erich Jaeger B.V., NL
LOS
Oct 20, 1999K991014CASE 8000 EXERCISE TESTING SYSTEM
General Electric Medical Systems Information Techn
LOS
Aug 19, 1999K991735MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS
General Electric Medical Systems Information Techn
LOS
Apr 16, 1999K990031NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES
Nihon Kohden America, Inc.
LOS
Apr 15, 1999K984504NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES
Nihon Kohden America, Inc.
LOS
Feb 2, 1999K990266MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
Micromedical Industries, Ltd.
LOS
Oct 6, 1998K981024QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM)
Marquette Medical Systems, Inc.
LOS
Sep 8, 1998K974352CARDIOVIEW 3000 SOFTWARE
Micromedical, Inc.
LOS
Aug 31, 1998K981066FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH
Fukuda Denshi USA, Inc.
LOS
Aug 21, 1998K972587ELECTROCARDIOGRAPHS
Dr. Lee Co., Ltd.
LOS
Jul 7, 1998K972255PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM
Pulse Biomedical, Inc.
LOS
Jun 23, 1998K981265PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA
Hewlett-Packard Co.
LOS
Jun 15, 1998K974087MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT
Hewlett-Packard Co.
LOS
May 12, 1998K973922ARCHIMED 4210 AND 4220
Biosound Esaote, Inc.
LOS
May 7, 1998K980495MUSE CARDIOVASCULAR INFORMATION SYSTEM
Marquette Medical Systems, Inc.
LOS
Mar 12, 1998K973403CARDIOSMART ST
Marquette Medical Systems, Inc.
LOS
Feb 6, 1998K974199ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION
Marquette Medical Systems, Inc.
LOS
Dec 2, 1997K971440FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH
Fukuda Denshi USA, Inc.
LOS
Jun 25, 1997K970879CARDIOVIT CS-200
Schiller America, Inc.
LOS
Feb 21, 1997K964750EAGLE 4000 PATIENT MONITOR
Marquette Electronics, Inc.
LOS
Jan 27, 1997K962854HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT
Cardio Control BV
LOS
Dec 10, 1996K961223MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS
Criticare Systems, Inc.
LOS
Nov 1, 1996K961272NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
Nihon Kohden America, Inc.
LOS
Jul 31, 1996K961014QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH
Quinton, Inc.
LOS
May 15, 1996K954980PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO
Hewlett-Packard Co.
LOS
Apr 23, 1996K946281ECLIPSE 4 ELECTROCARDIOGRAPH
Burdick, Inc.
LOS
Apr 4, 1996K951130CARDIOSOFT/CARDIOSYS
Marquette Electronics, Inc.
LOS
Jan 4, 1996K951978HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE PREDICITIVE INSTRUMENT (ACI-TIPT)
Hewlett-Packard Co.
LOS
Dec 19, 1995K953396CARDIOVIT AT-1C, AT-2C
Schiller America, Inc.
LOS
Aug 24, 1995K935589CENTRA HEART STATION
Marquette Electronics, Inc.
LOS
May 26, 1995K941282ECG FAX MODEM
Hewlett-Packard Co.
LOS
May 19, 1995K941462CARDIOVIT AT-5C
Schiller America, Inc.
LOS
May 17, 1995K943959ECLIPSE 4 ELECTROCARDIOGRAPH
Burdick, Inc.
LOS
Jul 26, 1994K935772HP M177XA CARDIOGRAPHS
Hewlett-Packard Co.
LOS
Apr 15, 1994K933143MODEL ELI 300 ELECTROCARDIOGRAPH
Mortara Instrument, Inc.
LOS
Mar 1, 1994K922394CARDIOFAX Q ECG-8420A
Nihon Kohden America, Inc.
LOS
Dec 6, 1993K923788SPACE LABS MODEL 90560
Spacelabs, Inc.
LOS
Nov 1, 1993K922898CARDIO PERFECT, CARDIO PERFECT MD
Cardio Control BV, NL
LOS
May 7, 1993K921669MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITION
Marquette Electronics, Inc.
LOS
Apr 21, 1993K922221SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM
Del Mar Avionics
LOS
Nov 10, 1992K915730MORTARA INSTRUMENT ODEL ELI 50I
Mortara Instrument, Inc.
LOS
Nov 3, 1992K914970CARDIOVIT CS-100
Schiller America, Inc.
LOS
Oct 21, 1992K921476INTERP-1000
Qmed, Inc.
LOS
Oct 9, 1992K915327ELITE II ELECTROCARDIOGRAPH,MODIFIED
Siemens Burdick, Inc.
LOS

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