FDA.reportPublic FDA data

WIPRO GE HEALTHCARE PRIVATE Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30077348883007734888WIPRO GE HEALTHCARE PRIVATE Ltd.1N2027-01-01122 (Part 1), JOHN F. WELCH TECHNOLOGY CENTRE, ODYSSEY AND GALIL EXPORT PROMOTIONAL INDUSTRIAL PARK, WHITEFIELD BANGALORE Karnataka IN 560066

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1346852013178386P870025FETAL ACOUSTIC STIMULATOR, MODEL 0146AAYMCP1988-08-31
1346851323320976K993751COROMETRICS MODEL 173 FETAL MONITORHGM2000-02-02
1346851020753966K993712BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEMFMZ1999-11-09
1346851089787345K993665LEGEND CRF FLUORO AND RAD SYSTEMKPR1999-11-12
1346851665070206K993407OHMEDA MEDICAL OMNIBEDFMZ2000-01-05
1346851165177655K991905COROMETRICS MODEL 171 AND 172 FETAL MONITORHGM1999-09-01
1346851676178048K982651COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERHEL1998-12-11
1346851334370594K974349OHMEDA-OHIO CARE PLUS INCUBATORFMZ1998-02-12
1346851018349888K973403CARDIOSMART STLOS1998-03-12
1346851712025503K973039LEGACY/LEGACY-D TABLEIXR1997-10-16
1346851355129694K971243OHMEDA INFANT RESUSCITATION SYSTEMBTM1997-12-02
1346851545775620K963058INFANT WARMER SYSTEMFMT1996-10-01
1346851357814808K962806OHMEDA-OHIO CAE PLUS INCUBATORFMZ1996-09-20
1346851065452841K943805PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHDJAA1994-09-23
1346851052191830K943360OHIO CARE PLUS INCUBATORFMZ1994-09-29
1346851457478268K924310PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPICLLZ1993-01-21
1346852028912771K921766OHIO INFANT WARMER SYSTEMFMT1993-04-23
1346851542030580K914487OHIO CARE PLUS INCUBATORFMZ1991-12-18
1346851417181997K913154OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATIONFMZ1991-09-13
1346851423501434K910902VMX MOBILE X-RAY SYSTEMIZL1991-09-09
1346851019514726K910260COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYSTHGM1991-03-15
1346851710006005K901585OHMEDA - OHIO(R) CARE PLUS INCUBATORFMZ1990-06-22
1346851451090475K894129BILIBLANKET PHOTOTHERAPY DEVICELBI1989-09-28
1346851824346668K884160OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEMFMT1988-11-21
1346851328078512K871399OHIO(R) CARE PLUS INCUBATORFMZ1987-06-05
1346851975797394K851449OHMEDA 5000 INFANT WARMER SYSTEMFMT1985-06-07
1346851904882389K843926PRESTILIX 1690IXR1984-12-17
1346851649810769K801320SFX-90 TABLE/SPOTFILMER W/FLUORICON L200JAA1980-07-21
1346852013638259K760466TABLE, X-RAY, RFX CLASSICALIXR1976-08-26
1346851964448704K254036Novii+ Wireless Patch SystemHGM2026-08-10
1346851205645253K232346Digital Expert Access with Remote ScanningLNH2023-10-27
1346851268411222K231964Novii+ Wireless Patch SystemHGM2023-12-08
1346851743458197K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK2023-12-13
1346851859468484K223491Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care SuiteQBS2023-05-25
1346851279198482K222586Mural Clinical ViewerMHX2022-12-21
1346851967980478K220732Mural Perinatal SurveillanceHGM2022-06-23
1346851160605239K213553Giraffe Incubator Carestation CS1FMZ2022-03-02
1346851410950676K213551Giraffe Omnibed Carestation CS1FMT2022-03-02
1346851179559812K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmQIH2021-10-29
1346851860639661K210982AMX NavigateIZL2021-04-28
1346851354832526K201628Panda iRes Warmer, Giraffe WarmerFMT2021-02-12
1346852059134781K183182Critical Care SuiteQFM2019-08-12
1346851324799321K183116Unity Network IDMWI2018-12-06
1346851960268141K182234Optima XR240amxIZL2018-09-06
1346851451298112K180995Vscan ExtendIYN2018-06-25
1346851694601952K173602Optima XR240amx, AutoGridIZL2018-01-12
1346851943400970K170199Unity Network IDMWI2017-05-12
1346851246122195K162990Optima XR240amxIZL2016-11-15
1346851610211832K162012CARESCAPE Central Station V2DXJ2016-09-15
1346851967158516K161588Vscan ExtendIYN2016-08-31
1346851552672737K152814Giraffe OmniBed Carestation CS1FMZ2016-03-17
1346851441303701K152809Giraffe Incubator Carestation CS1FMZ2015-12-31
1346851126872315K150193Customer Remote Console (CRC)LLZ2015-03-24
1346851533683446K142840Unity Network IDMWI2015-01-07
1346851482715967K142383Optima XR200amx, Optima XR220amxIZL2014-09-25
1346851831643512K141477DISCOVERY IQKPS2014-09-18
1346851171009157K140862MONICA NOVII WIRELESS PATCH SYSTEMOSP2014-08-27
1346851859804526K123309GIRAFFE AND PANDA WARMERSFMT2013-02-05
1346851782845215K123238ACHILLESMUA2013-02-25
1346851092803652K122267GIRAFFE AND PANDA WARMERSFMT2012-10-02
1346851295245947K121625LULLABY TM WARMERFMT2012-09-14
1346851286107523K120820GIRAFFE BLUE SPOT PT LITELBI2012-06-08
1346852067999729K120168LULLABY LED PHOTTHERAPY SYSTEMLBI2012-05-02
1346851987710570K112754IVENT101CBK2012-06-15
1346851163801857K112371LOGIQ P3IYN2011-09-27
1346851390430168K110556MINI TELEMETRY SYSTEMHGM2011-07-19
1346851034492113K110266MAC 5500 HD, MAC 3500DPS2011-04-29
1346851318534575K103765MAC 600 RESTING ECG ANALYSIS SYSTEMDPS2011-05-17
1346851687408750K103678CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEMDQK2011-02-16
1346851665802883K103633ACHILLESMUA2011-05-11
1346851792178029K103476BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMXIZL2011-06-16
1346851995221237K103432UNITY NETWORK IDMWI2010-12-17
1346852058851185K102389NAVIGATOR APPLICATIONS SUITEBSZ2011-06-10
1346851483741327K102104GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMIYN2010-10-01
1346852050581818K101804GIRAFFE AND PANDA WARMERSFMT2010-07-21
1346851501442077K101788GIRAFFE OMNIBEDFMZ2010-07-21
1346851528510167K101778GIRAFFE INCUBATORFMZ2010-07-21
1346851183577111K090697MODIFICATION TO: GIRAFFE AND PANDA WARMERFMT2009-04-16
1346851403182446K081091PRECISION 500D R&F X-RAY SYSTEMJAA2008-06-11
1346851702378223K073694IVENT 2001 MRI CONDITIONALCBK2008-05-30
1346851565981066K072976MODEL 250CX SERIES MATERNAL/FETAL MONITORHGM2007-12-20
1346851966626483K072512MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)FMZ2007-10-03
1346851274175530K072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)FMT2007-08-27
1346851833781574K072075MODIFICATION TO GE LOGIQ A3IYN2007-08-29
1346851612161729K071828LULLABYLBI2007-08-06
1346851081523357K070377GIRAFFE AND PANDA WARMERFMT2007-07-11
1346851395478094K070247GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEMBTM2007-04-20
1346851800776822K070210GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEMBTL2007-04-20
1346851969581093K053568BILISOFT PHOTOTHERAPY SYSTEMLBI2006-04-17
1346851883556991K052897GE DEFINIUM AMX 700, MODEL AMX 700IZL2005-11-08
1346851016603733K050583MODEL 250 SERIES MATERNAL/FETAL MONITORHGM2005-06-21
1346851506699234K040068BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEMFMZ2004-04-16
1346851890530500K032252MODEL 120 SERIES MATERNAL/FETAL MONITORHGM2003-08-21
1346851572004204K031561CARDIOSOFT/CASE CARDIAC TESTING SYSTEMDQK2003-08-01
1346851559664851K021016AMX-4 PLUS MOBILE X-RAY SYSTEMIZL2002-06-17
1346851316358309K020547OHMEDA MEDICAL GIRAFFE INCUBATORFMZ2002-05-09
1346851415592203K020543OHMEDA MEDICAL GIRAFFE OMNIBEDFMZ2002-05-09
1346851316129488K020263LOGIQ 3IYN2002-02-06
1346851614429865K012560GE LOGIQ A100 MP, MODEL 2272413IYO2001-08-23
1346851450154481K011624EXPEDIO 500D R&F X-RAY SYSTEMJAA2001-06-08
1346852024594692K011549OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEMLBI2001-07-19
1346851365700415K010222OHMEDA MEDICAL GIRAFFE INCUBATORFMZ2001-03-21
1346851761048161
1346851811654918
1346852017828174
1346852068122038
1346851069296598
1346851131247706
1346851176718031
1346851639988236
1346851716419246
1346851810646975

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMZ192022-03-02
FMT132022-03-02
HGM102026-08-10
IZL92021-04-28
IYN62018-06-25
LBI62012-06-08
MWI42018-12-06
JAA42008-06-11
DQK32023-12-13
IXR31997-10-16
LLZ22015-03-24
OSP22014-08-27
MUA22013-02-25
CBK22012-06-15
DPS22011-05-17
BTM22007-04-20
LNH12023-10-27
QBS12023-05-25
MHX12022-12-21
QIH12021-10-29
QFM12019-08-12
DXJ12016-09-15
KPS12014-09-18
BSZ12011-06-10
BTL12007-04-20
IYO12001-08-23
KPR11999-11-12
HEL11998-12-11
LOS11998-03-12
MCP 11988-08-31