FDA 510(k) Applications for Medical Device Product Code "LOS"
(System, Ecg Analysis)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K090895 | BIONET CO., LTD. | EKG-PLUS II SOFTWARE | 08/26/2009 |
| K011328 | BIONET COMPANY LTD | CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH | 11/21/2001 |
| K023034 | BIONET COMPANY LTD | CARDIOTOUCH-3000 | 11/14/2002 |
| K973922 | BIOSOUND ESAOTE, INC. | ARCHIMED 4210 AND 4220 | 05/12/1998 |
| K946281 | BURDICK, INC. | ECLIPSE 4 ELECTROCARDIOGRAPH | 04/23/1996 |
| K962854 | CARDIO CONTROL BV | HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT | 01/27/1997 |
| K961223 | CRITICARE SYSTEMS, INC. | MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS | 12/10/1996 |
| K972587 | DR. LEE CO., LTD. | ELECTROCARDIOGRAPHS | 08/21/1998 |
| K984465 | ERICH JAEGER B.V. | OXYCONALPHA WITH OPTION ECG | 10/27/1999 |
| K971440 | FUKUDA DENSHI USA, INC. | FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH | 12/02/1997 |
| K981066 | FUKUDA DENSHI USA, INC. | FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH | 08/31/1998 |
| K991014 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN | CASE 8000 EXERCISE TESTING SYSTEM | 10/20/1999 |
| K991735 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN | MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS | 08/19/1999 |
| K951978 | HEWLETT-PACKARD CO. | HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE PREDICITIVE INSTRUMENT (ACI-TIPT) | 01/04/1996 |
| K974087 | HEWLETT-PACKARD CO. | MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT | 06/15/1998 |
| K954980 | HEWLETT-PACKARD CO. | PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO | 05/15/1996 |
| K981265 | HEWLETT-PACKARD CO. | PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA | 06/23/1998 |
| K951130 | MARQUETTE ELECTRONICS, INC. | CARDIOSOFT/CARDIOSYS | 04/04/1996 |
| K964750 | MARQUETTE ELECTRONICS, INC. | EAGLE 4000 PATIENT MONITOR | 02/21/1997 |
| K974199 | MARQUETTE MEDICAL SYSTEMS, INC. | ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION | 02/06/1998 |
| K973403 | MARQUETTE MEDICAL SYSTEMS, INC. | CARDIOSMART ST | 03/12/1998 |
| K980495 | MARQUETTE MEDICAL SYSTEMS, INC. | MUSE CARDIOVASCULAR INFORMATION SYSTEM | 05/07/1998 |
| K981024 | MARQUETTE MEDICAL SYSTEMS, INC. | QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM) | 10/06/1998 |
| K990266 | MICROMEDICAL INDUSTRIES, LTD. | MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE | 02/02/1999 |
| K974352 | MICROMEDICAL, INC. | CARDIOVIEW 3000 SOFTWARE | 09/08/1998 |
| K993616 | NASIFF ASSOC., INC. | CARDIO-CARD INTERPRETATION SYSTEM I | 04/10/2000 |
| K990031 | NIHON KOHDEN AMERICA, INC. | NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES | 04/16/1999 |
| K984504 | NIHON KOHDEN AMERICA, INC. | NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES | 04/15/1999 |
| K961272 | NIHON KOHDEN AMERICA, INC. | NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES | 11/01/1996 |
| K073376 | PHILIPS MEDICAL SYSTEMS | PHILIPS ECG ALGORITHM | 04/11/2008 |
| K972255 | PULSE BIOMEDICAL, INC. | PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM | 07/07/1998 |
| K083749 | QRS DIAGNOSTIC, LLC. | CARDIOVIEW32 REVIEW MODULE | 03/10/2009 |
| K961014 | QUINTON, INC. | QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH | 07/31/1996 |
| K970879 | SCHILLER AMERICA, INC. | CARDIOVIT CS-200 | 06/25/1997 |
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