FDA.reportPublic FDA data

Charlemagne Chua

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80302293002807739Charlemagne Chua1N2026-01-0115353 Barranca Pkwy -- Irvine CA US 92618
96112523002807720Charlemagne Chua1N2026-01-0115353 Barranca Pkwy -- Irvine CA US 92618
30074818933007481893Charlemagne Chua1N2026-01-0115353 Barranca Pkwy -- Irvine CA US 92618
30135011103013501110Charlemagne Chua1N2026-01-0115353 Barranca Pkwy -- Irvine CA US 92618
30305164503030516450Charlemagne Chua1N2026-01-0115353 Barranca Parkway Irvine CA US 92618

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
104741990331356K992742NEUROFAX, MODEL EEG-1100AOLV1999-10-14
104751990331356K992742NEUROFAX, MODEL EEG-1100AOLV1999-10-14
104741672588205K991899NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIESGWF1999-09-01
104741651367674K990063NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIESCCK1999-06-09
978821651367674K990063NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIESCCK1999-06-09
2006911651367674K990063NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIESCCK1999-06-09
104741951239781K990031NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIESLOS1999-04-16
104741077831646K984504NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIESLOS1999-04-15
104741053125779K974292NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIESDQA1998-06-08
104741770817014K973918NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIESDRT1998-01-13
104741522417448K961272NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIESLOS1996-11-01
104741342823890K946175NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTERDRG1995-11-22
104741622561829K945944NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEMDSI1995-11-27
104741908808766K945578NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTERDRG1995-11-14
104741651440970K944678NIHON KOHDEN ELECTROENCEPHALOGRAPHGWQ1995-05-22
104741225506935K944422BSM-8800A BEDSIDE MONITORDSI1995-05-24
104741255742583K944027AG-839PA CO2 MODULE AND ACCESSORIESBXO1994-08-31
104741301296350K935877NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350ADSI1995-05-24
104741302352476K922394CARDIOFAX Q ECG-8420ALOS1994-03-01
104741240471587K920743DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSISDSI1992-09-03
104741350093982K920154BSM-8800A BEDSIDE MONITORDSI1992-12-18
104741981829094K913117ZB-860PA MULTIPARAMETER TRANSMITTERDSI1992-04-29
104741646878805K912744ORG-8200A UNIVERSAL SIGNAL HOUSINGDSI1991-12-09
104751646878805K912744ORG-8200A UNIVERSAL SIGNAL HOUSINGDSI1991-12-09
104741895636623K910629AP-860PA NIBP MODULEDQA1991-05-14
104741476813755K904696WEP-8430A TELEMETRY CENTRAL STATIONDRT1991-02-07
104741186426250K901034MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRALDRT1990-04-19
104741321167599K900272NKA MODELS AB-601G AND AB-621GDPS1990-01-31
104741762966400K896359AG-820PA FI02 MODULECCL1990-03-09
104751762966400K896359AG-820PA FI02 MODULECCL1990-03-09
104741144398777K894693AP-851PA NIBP MODULEDXN1989-10-02
104741077734827K894692BEDSIDE MONITORS, BSM-8301A, BSM-8302ADSI1989-10-02
104741882724375K894691MODEL AO-800PA CO2 MODULECCK1989-12-22
104741006497404K894631NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.DPW1990-01-19
104741633145436K894492NKA MODEL SEC-3102 CARDIAC STIMULATORDRO1989-12-20
104741273507268K891486AR-800PA RESPIRATION MODULEBZQ1989-10-24
104741449886942K890736TFV-2300 INFUSION PUMPFRN1990-07-09
104741040090208K884537AE-800PA EEG MODULEGWQ1988-12-29
104741912809998K884536AL-800PA PULSE OXIMETER MODULEDQA1989-02-06
104741307787646K884050CNS-8200A CENTRAL NURSES STATIONDQA1989-02-23
104741823031408K882254OEC-7102 ECG/NIBP MONITORDPS1988-11-09
104751823031408K882254OEC-7102 ECG/NIBP MONITORDPS1988-11-09
104742044940208K881831WS 800R THERMAL ARRAY RECORDERDSF1988-07-14
104741847808944K881307OLV 1100; OLV 1200 PULSE OXIMETERSDQA1988-11-04
104741987239082K872241LIFESCOPE 12, BSM 8500A PATIENT MONITORDSI1987-09-30
104741559027786K870795EMG ELECTRODES AND EXTENSION CORDSIKT1987-03-13
978821559027786K870795EMG ELECTRODES AND EXTENSION CORDSIKT1987-03-13
2006911559027786K870795EMG ELECTRODES AND EXTENSION CORDSIKT1987-03-13
104741252490647K865031ELECTROCARDIOGRAPHDPS1987-02-19
104741889468296K862799SKIN PUREGYB1986-11-13
104751889468296K862799SKIN PUREGYB1986-11-13
2006911889468296K862799SKIN PUREGYB1986-11-13
104741769111127K862463LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR RECDRT1986-12-05
104741381828179K862462LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR RECBZQ1987-02-03
104741549552029K860239ORG-7201 MULTIPARAMETER TELEMETRY MONITORDRG1986-06-26
104741054769693K860237OMF-7101 FETAL MONITORHGM1986-09-05
104741924567895K860210ELEFIX ELECTRODE CREAMGYB1986-07-01
978821924567895K860210ELEFIX ELECTRODE CREAMGYB1986-07-01
2006911924567895K860210ELEFIX ELECTRODE CREAMGYB1986-07-01
104741005646936K854866LONG TERM RECORDER RAG 1200DSF1986-04-09
104741146461361K854371MTC 6210A CARDIAC OUTPUT COMPUTERDXG1987-02-19
104741159394518K854370MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITORDXN1986-04-28
104751159394518K854370MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITORDXN1986-04-28
104741662794532K854369WEP 7604 TELEMETRY MONITORDXH1986-02-28
104741935233887K852270LIFESCOPE 8 DEC-8108A AND DEC-8204ADSI1985-07-30
104741935802958K844911ARRHYTHMIA CENTRAL-OGP-7201DRT1985-01-18
104741428258920K843287ARRHYTHMIA CENTRAL OCC-7101DSI1984-10-18
104741973023381K842381SLS 3500 LED VISUAL STIMULATORGWE1984-11-09
104741395682539K841502LIFESCOPE 6 OEC-6105DRT1984-08-28
104741189316986K841501LIFESCOPE 6 OEC-6102DRT1984-08-28
104741639818326K841500LIFESCOPE 6 OEC-6201DSI1984-08-28
104741835961559K841499LIFESCOPE IIDRT1984-08-28
104741286029123K841498C02 MONITOR-OIR-7101CCK1984-05-14
104741677640417K823563EEG & RESPIRATION MODULES POLYGRAPHBZQ1983-01-12
104741617362656K823562EMG MODULES FOR POLYGRAPH SYSTEMIKN1983-01-14
104741559376202K823561URETHRAL PRESSURE PROFILE & TEMP. MODULFAP1983-01-07
104741466337249K823281MODEL RM 6000, 6100,6200 POLYGRAPHDPS1982-12-22
104741050484797K823249LIFESCOPE II/FOURDRG1982-11-24
104741716223230K823220COSMOSDPS1982-11-24
104741547004674K823140ELECTROENCEPHALOGRAPHGWQ1982-12-07
104741063261527K820742NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100DPW1982-04-15
104741652756862K813444NIHON KOHDEN HEART MONITORS OMP 7101-02DRT1981-12-29
104741500534220K813266NIHON KOHDEN ELECTROCARDIOGRAPHDRS1982-01-29
104741991317826K810712ELECTRONIC SPIROMETER MODEL MFR-8100BTY1981-03-24
104742014194714K810357STRESS TEST SYSTEMDPS1981-03-11
104741628443871K802305MLC-4200 CARDIAC OUTPUT COMPUTERDXG1980-10-10
104741851069517K800005ECG MONITOR OSCILLOSCOPE MODEL OEC-3100DPS1980-03-05
104741500180325K800004ECG MONITOR OSCILLOSCOPE MODEL OEC-3200DPS1980-03-05
104741144524690K792678CARDIAC OUTPUT COMPUTER, M-MLC-4100DXG1980-01-09
104741008156804K791149STIMULATOR MODEL SSS-1101GWE1979-09-17
104741135168159K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK2025-06-10
978821135168159K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK2025-06-10
2006911135168159K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK2025-06-10
104741981150320K223567CNS-2101 Central MonitorMSX2023-07-31
978821981150320K223567CNS-2101 Central MonitorMSX2023-07-31
2006911981150320K223567CNS-2101 Central MonitorMSX2023-07-31
104741685922130K220976Life Scope PT BSM-1700 Series Bedside MonitorKOI2022-07-21
104751685922130K220976Life Scope PT BSM-1700 Series Bedside MonitorKOI2022-07-21
2006911685922130K220976Life Scope PT BSM-1700 Series Bedside MonitorKOI2022-07-21
104741434330346K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMKOI2021-12-29
104751434330346K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMKOI2021-12-29
2006911434330346K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMKOI2021-12-29
104741812109675K203435Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring SystemMHX2021-07-16
104751812109675K203435Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring SystemMHX2021-07-16
2006911812109675K203435Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring SystemMHX2021-07-16
104741667617011K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 SeriesKOI2021-05-02
104751667617011K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 SeriesKOI2021-05-02
2006911667617011K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 SeriesKOI2021-05-02
104741220682259K191975Elefix V Paste for EEG & EMGGYB2020-02-07
978821220682259K191975Elefix V Paste for EEG & EMGGYB2020-02-07
2006911220682259K191975Elefix V Paste for EEG & EMGGYB2020-02-07
104741699788087K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorMWI2019-05-28
104751699788087K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorMWI2019-05-28
104751415096514K183529AE-120A EEG Head SetOMC2019-03-19
104741440083996K171765Nihon Kohden CO2 MonitorCCK2017-10-11
104751440083996K171765Nihon Kohden CO2 MonitorCCK2017-10-11
2006911440083996K171765Nihon Kohden CO2 MonitorCCK2017-10-11
104741475918561K171124Nihon Kohden Wireless Input Unit WEE-1200GWQ2017-08-25
104751475918561K171124Nihon Kohden Wireless Input Unit WEE-1200GWQ2017-08-25
2006911475918561K171124Nihon Kohden Wireless Input Unit WEE-1200GWQ2017-08-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MHX412021-07-16
CCK372025-06-10
DPS212007-08-30
DSI192016-04-08
OLV152008-01-11
GWQ142017-08-25
GWF132015-04-24
OMA112017-05-19
DRT112005-02-03
KOI92022-07-21
GYB92020-02-07
DRG72007-06-29
DQA51998-06-08
MWI42019-05-28
IKN42001-06-28
LOS41999-04-16
MSX32023-07-31
OLT32008-08-29
BZQ31989-10-24
DXN31989-10-02
IKT31987-03-13
DXG31987-02-19
GYC22011-08-04
CCL21990-03-09
DPW21990-01-19
DSF21988-07-14
GWE21984-11-09
OMC12019-03-19
BXO11994-08-31
FRN11990-07-09
DRO11989-12-20
HGM11986-09-05
DXH11986-02-28
FAP11983-01-07
DRS11982-01-29
BTY11981-03-24