MAC 2000 ECG ANALYSIS SYSTEM
WIPRO GE HEALTHCARE
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9613936 | 1000571342 | WIPRO GE HEALTHCARE PRIVATE LTD | 1 | N | 2026-01-01 | 122, Part I, EXPORT PROMOTIONAL INDUSTRIAL PARK WHITEFIELD, BANGALORE Karnataka IN 560 066 |
| 9617277 | 3003190524 | Wipro GE Healthcare Private Ltd. | 1 | N | 2026-01-01 | 4, Kadugodi Industrial Area Bangalore Karnataka IN 560067 |
| 3007734888 | 3007734888 | WIPRO GE HEALTHCARE PRIVATE Ltd. | 1 | N | 2026-01-01 | 122 (Part 1), JOHN F. WELCH TECHNOLOGY CENTRE, ODYSSEY AND GALIL EXPORT PROMOTIONAL INDUSTRIAL PARK, WHITEFIELD BANGALORE Karnataka IN 560066 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00840682116992 | Mini Telemetry System - 2051444-004 | +1(414)355-5000 | xx@xx.xx |
| 00840682117012 | Mini Telemetry System - 2051440-003 | +1(414)355-5000 | xx@xx.xx |
| 00840682117067 | Mini Telemetry System - 2051440-004 | +1(414)355-5000 | xx@xx.xx |
| 00840682117128 | Mini Telemetry System - 2051440-002 | +1(414)355-5000 | xx@xx.xx |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 26614 | 2013178386 | P870025 | FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY | MCP | 1988-08-31 |
| 134685 | 2013178386 | P870025 | FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY | MCP | 1988-08-31 |
| 26614 | 1323320976 | K993751 | COROMETRICS MODEL 173 FETAL MONITOR | HGM | 2000-02-02 |
| 134685 | 1323320976 | K993751 | COROMETRICS MODEL 173 FETAL MONITOR | HGM | 2000-02-02 |
| 134685 | 1020753966 | K993712 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM | FMZ | 1999-11-09 |
| 134685 | 1089787345 | K993665 | LEGEND CRF FLUORO AND RAD SYSTEM | KPR | 1999-11-12 |
| 134685 | 1665070206 | K993407 | OHMEDA MEDICAL OMNIBED | FMZ | 2000-01-05 |
| 26614 | 1165177655 | K991905 | COROMETRICS MODEL 171 AND 172 FETAL MONITOR | HGM | 1999-09-01 |
| 134685 | 1165177655 | K991905 | COROMETRICS MODEL 171 AND 172 FETAL MONITOR | HGM | 1999-09-01 |
| 26614 | 2061004286 | K991735 | MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS | LOS | 1999-08-19 |
| 26614 | 1676178048 | K982651 | COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER | HEL | 1998-12-11 |
| 134685 | 1676178048 | K982651 | COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER | HEL | 1998-12-11 |
| 26604 | 1686591810 | K980157 | PREMIER 7000 CTL SPINE COIL | MOS | 1998-04-13 |
| 134685 | 1334370594 | K974349 | OHMEDA-OHIO CARE PLUS INCUBATOR | FMZ | 1998-02-12 |
| 26614 | 1018349888 | K973403 | CARDIOSMART ST | LOS | 1998-03-12 |
| 134685 | 1018349888 | K973403 | CARDIOSMART ST | LOS | 1998-03-12 |
| 134685 | 1712025503 | K973039 | LEGACY/LEGACY-D TABLE | IXR | 1997-10-16 |
| 134685 | 1355129694 | K971243 | OHMEDA INFANT RESUSCITATION SYSTEM | BTM | 1997-12-02 |
| 134685 | 1545775620 | K963058 | INFANT WARMER SYSTEM | FMT | 1996-10-01 |
| 134685 | 1357814808 | K962806 | OHMEDA-OHIO CAE PLUS INCUBATOR | FMZ | 1996-09-20 |
| 134685 | 1065452841 | K943805 | PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD | JAA | 1994-09-23 |
| 134685 | 1052191830 | K943360 | OHIO CARE PLUS INCUBATOR | FMZ | 1994-09-29 |
| 134685 | 1457478268 | K924310 | PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC | LLZ | 1993-01-21 |
| 26604 | 1808495795 | K923264 | GENERAL PURPOSE FLEX COIL | LNH | 1992-09-30 |
| 134685 | 2028912771 | K921766 | OHIO INFANT WARMER SYSTEM | FMT | 1993-04-23 |
| 134685 | 1542030580 | K914487 | OHIO CARE PLUS INCUBATOR | FMZ | 1991-12-18 |
| 134685 | 1417181997 | K913154 | OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION | FMZ | 1991-09-13 |
| 134685 | 1423501434 | K910902 | VMX MOBILE X-RAY SYSTEM | IZL | 1991-09-09 |
| 26614 | 1019514726 | K910260 | COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST | HGM | 1991-03-15 |
| 134685 | 1019514726 | K910260 | COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST | HGM | 1991-03-15 |
| 134685 | 1710006005 | K901585 | OHMEDA - OHIO(R) CARE PLUS INCUBATOR | FMZ | 1990-06-22 |
| 134685 | 1451090475 | K894129 | BILIBLANKET PHOTOTHERAPY DEVICE | LBI | 1989-09-28 |
| 134685 | 1824346668 | K884160 | OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM | FMT | 1988-11-21 |
| 134685 | 1328078512 | K871399 | OHIO(R) CARE PLUS INCUBATOR | FMZ | 1987-06-05 |
| 134685 | 1975797394 | K851449 | OHMEDA 5000 INFANT WARMER SYSTEM | FMT | 1985-06-07 |
| 134685 | 1904882389 | K843926 | PRESTILIX 1690 | IXR | 1984-12-17 |
| 134685 | 1649810769 | K801320 | SFX-90 TABLE/SPOTFILMER W/FLUORICON L200 | JAA | 1980-07-21 |
| 134685 | 2013638259 | K760466 | TABLE, X-RAY, RFX CLASSICAL | IXR | 1976-08-26 |
| 26614 | 1228006311 | K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | IYN | 2026-03-24 |
| 26614 | 2053786010 | K260398 | LOGIQ e | IYN | 2026-05-26 |
| 26614 | 1684322365 | K253366 | LOGIQ Fortis | IYN | 2026-01-07 |
| 26614 | 1111491994 | K252328 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | IYN | 2025-11-24 |
| 26614 | 2053695773 | K251985 | LOGIQ E10 | IYN | 2025-10-29 |
| 26614 | 1078030117 | K251963 | LOGIQ E10s | IYN | 2025-10-29 |
| 26614 | 1846202890 | K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | IYN | 2025-07-25 |
| 26614 | 1040314840 | K251169 | Vivid Pioneer | IYN | 2025-07-10 |
| 26614 | 1833596315 | K250543 | Voluson™ Performance 16; Voluson™ Performance 18 | IYN | 2025-05-29 |
| 26614 | 1273874788 | K243628 | Vivid T9/Vivid T8 | IYN | 2025-02-11 |
| 26614 | 1905736941 | K243620 | Vivid iq | IYN | 2025-02-11 |
| 26614 | 1519616603 | K242168 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | IYN | 2024-12-20 |
| 26614 | 1955831828 | K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | IYN | 2024-10-02 |
| 26614 | 1829127751 | K240111 | Venue | IYN | 2024-06-10 |
| 26614 | 1060568579 | K240053 | Venue Go | IYN | 2024-06-10 |
| 26614 | 1574908925 | K234106 | Venue Fit | IYN | 2024-06-10 |
| 26614 | 1414324903 | K233692 | Voluson Signature 20, Voluson Signature 18 | IYN | 2024-03-07 |
| 26614 | 1233237274 | K232381 | LOGIQ Totus | IYN | 2023-12-07 |
| 26614 | 1205645253 | K232346 | Digital Expert Access with Remote Scanning | LNH | 2023-10-27 |
| 134685 | 1205645253 | K232346 | Digital Expert Access with Remote Scanning | LNH | 2023-10-27 |
| 26614 | 1507556663 | K232186 | LOGIQ e | IYN | 2023-11-03 |
| 26614 | 1680768656 | K231989 | LOGIQ E10s, LOGIQ Fortis | IYN | 2023-11-07 |
| 26614 | 1803846471 | K231966 | LOGIQ E10 | IYN | 2023-11-07 |
| 26614 | 1113056635 | K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | IYN | 2023-10-30 |
| 134685 | 1268411222 | K231964 | Novii+ Wireless Patch System | HGM | 2023-12-08 |
| 134685 | 1743458197 | K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | DQK | 2023-12-13 |
| 26614 | 1146882666 | K230346 | Voluson SWIFT; Voluson SWIFT+ | IYN | 2023-06-20 |
| 26614 | 1550945944 | K223832 | Vivid S60N, Vivid S70N | IYN | 2023-02-16 |
| 134685 | 1859468484 | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | QBS | 2023-05-25 |
| 26614 | 1484427763 | K223407 | Versana Essential | IYN | 2023-02-15 |
| 134685 | 1279198482 | K222586 | Mural Clinical Viewer | MHX | 2022-12-21 |
| 26614 | 1496863674 | K221148 | Vivid iq | IYN | 2022-07-18 |
| 26614 | 1355744278 | K221147 | Vivid T8, Vivid T9 | IYN | 2022-07-18 |
| 26614 | 1849210467 | K220882 | Vivid E80, Vivid E90, Vivid E95 | IYN | 2022-07-22 |
| 26614 | 1470155993 | K220851 | Venue | IYN | 2022-06-27 |
| 26614 | 1207379269 | K220848 | Venue Fit | IYN | 2022-06-27 |
| 26614 | 1255747394 | K220800 | Venue Go | IYN | 2022-06-21 |
| 134685 | 1967980478 | K220732 | Mural Perinatal Surveillance | HGM | 2022-06-23 |
| 26614 | 1583853416 | K220619 | Vivid S60N, Vivid S70N | IYN | 2022-07-15 |
| 26614 | 1271216718 | K220446 | Versana Balance | IYN | 2022-05-11 |
| 26614 | 1542794144 | K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | IYN | 2022-06-06 |
| 26614 | 1665287961 | K214039 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | IYN | 2022-03-22 |
| 26614 | 1871704527 | K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | IYN | 2022-01-13 |
| 134685 | 1160605239 | K213553 | Giraffe Incubator Carestation CS1 | FMZ | 2022-03-02 |
| 134685 | 1410950676 | K213551 | Giraffe Omnibed Carestation CS1 | FMT | 2022-03-02 |
| 26614 | 1828249342 | K211524 | LOGIQ E10s, LOGIQ Fortis | IYN | 2021-08-27 |
| 26614 | 1373506904 | K211488 | LOGIQ E10 | IYN | 2021-09-10 |
| 26614 | 1215438851 | K211216 | Vivid S60N / Vivid S70N | IYN | 2021-06-09 |
| 134685 | 1179559812 | K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | QIH | 2021-10-29 |
| 134685 | 1860639661 | K210982 | AMX Navigate | IZL | 2021-04-28 |
| 26614 | 1054366508 | K210438 | Versana Premier | IYN | 2021-09-10 |
| 26614 | 1045794044 | K203137 | Venue Fit | IYN | 2020-12-29 |
| 26614 | 1860949993 | K203114 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | IYN | 2021-01-08 |
| 26614 | 2049977122 | K202658 | Vivid E80/ Vivid E90/ Vivid E95 | IYN | 2021-03-05 |
| 26614 | 1320605005 | K202233 | Venue Go | IYN | 2020-11-18 |
| 26614 | 1480472745 | K202132 | Venue | IYN | 2020-11-13 |
| 134685 | 1354832526 | K201628 | Panda iRes Warmer, Giraffe Warmer | FMT | 2021-02-12 |
| 26614 | 1552540714 | K200998 | Versana Active | IYN | 2020-06-11 |
| 26614 | 1085334430 | K200851 | Vivid T8, Vivid T9 | IYN | 2020-09-09 |
| 26614 | 1657862593 | K200743 | Vivid E80/ Vivid E90/ Vivid E95 | IYN | 2020-07-23 |
| 26614 | 1803578892 | K200708 | Vivid iq | IYN | 2020-09-09 |
| 26614 | 1041951822 | K200497 | Vivid S60N, Vivid S70N | IYN | 2020-07-16 |
| 26614 | 1615631748 | K200138 | Versana Premier | IYN | 2020-07-01 |
| 26614 | 1862225688 | K200119 | LOGIQ E10s | IYN | 2020-04-01 |
| 26614 | 1545666808 | K192159 | Voluson E6, Voluson E8, Voluson E10 | IYN | 2019-08-29 |
| 26614 | 1392054813 | K191798 | Versana Active | IYN | 2019-08-09 |
| 26614 | 1045577832 | K191792 | Versana Balance | IYN | 2019-08-09 |
| 26614 | 1457689308 | K183362 | Venue GO | IYN | 2019-01-28 |
| 134685 | 2059134781 | K183182 | Critical Care Suite | QFM | 2019-08-12 |
| 134685 | 1324799321 | K183116 | Unity Network ID | MWI | 2018-12-06 |
| 26614 | 1901623583 | K182450 | Vivid S60N, Vivid S70N | IYN | 2018-10-19 |
| 26614 | 2014006386 | K182277 | Versana Premier | IYN | 2018-11-21 |
| 134685 | 1960268141 | K182234 | Optima XR240amx | IZL | 2018-09-06 |
| 26614 | 1975945052 | K181985 | Voluson E6, Voluson E8, Voluson E10 | IYN | 2018-11-15 |
| 26614 | 1745719114 | K181934 | Vivid T8, Vivid T9 | IYN | 2018-11-06 |
| 26614 | 1565149051 | K181727 | Vivid iq | IYN | 2018-12-06 |
| 26614 | 1649812527 | K181685 | Vivid E80, Vivid E90, Vivid E95 | IYN | 2018-10-25 |
| 134685 | 1451298112 | K180995 | Vscan Extend | IYN | 2018-06-25 |
| 26614 | 1426315530 | K180599 | Venue | IYN | 2018-05-02 |
| 26614 | 1206091853 | K180374 | Voluson S8/ Voluson S10/ Voluson S10 Expert | IYN | 2018-03-13 |
| 26604 | 1155765179 | K173816 | NM/CT 850, NM/CT 860 | KPS | 2018-04-17 |
| 134685 | 1694601952 | K173602 | Optima XR240amx, AutoGrid | IZL | 2018-01-12 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IYN | 115 | 2026-05-26 |
| LNH | 20 | 2023-10-27 |
| FMZ | 19 | 2022-03-02 |
| HGM | 16 | 2023-12-08 |
| FMT | 14 | 2022-03-02 |
| IZL | 9 | 2021-04-28 |
| LBI | 8 | 2012-06-08 |
| DPS | 7 | 2014-01-23 |
| MOS | 5 | 2013-02-22 |
| MWI | 4 | 2018-12-06 |
| KPS | 4 | 2018-04-17 |
| IYO | 4 | 2012-04-19 |
| JAA | 4 | 2008-06-11 |
| DQK | 3 | 2023-12-13 |
| LLZ | 3 | 2015-03-24 |
| LOS | 3 | 1999-08-19 |
| IXR | 3 | 1997-10-16 |
| OSP | 2 | 2014-08-27 |
| MUA | 2 | 2013-02-25 |
| CBK | 2 | 2012-06-15 |
| BTM | 2 | 2007-04-20 |
| HEL | 2 | 1998-12-11 |
| MCP | 2 | 1988-08-31 |
| QBS | 1 | 2023-05-25 |
| MHX | 1 | 2022-12-21 |
| QIH | 1 | 2021-10-29 |
| QFM | 1 | 2019-08-12 |
| DXJ | 1 | 2016-09-15 |
| BSZ | 1 | 2011-06-10 |
| BTL | 1 | 2007-04-20 |
| KPR | 1 | 1999-11-12 |
WIPRO GE HEALTHCARE
WIPRO GE HEALTHCARE PRIVATE, LTD.
WIPRO GE HEALTHCARE PRIVATE, LTD.
WIPRO GE HEALTHCARE PRIVATE, LTD.
WIPRO GE HEALTHCARE PRIVATE, LTD.
WIPRO GE HEALTHCARE PRIVATE, LTD.
2016-06-24
2016-06-24
2016-06-24
2016-06-24
2016-06-24
2018-10-29
2018-11-01
2018-11-01
2016-06-24
2016-06-24
2016-06-24
2016-06-24
2016-06-24
2016-06-24
2016-06-24
2016-06-24
2016-06-24
2016-06-24
2016-06-24
2022-12-06