FDA 510(k) Applications for Medical Device:
Flowmeter, Blood, Cardiovascular

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K872068 ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY.
BOTHELL WA 98041 3003
K972213 ALAN S. LEE 2121 W BEACON AVE.
ANAHEIM CA 92804
K912562 APPLIED BIOMETRICS, INC. 6269 BURY DR.
EDEN PRAIRIE MN 55346
K031153 ARROW INTL., INC. 2400 BERNVILLE RD.
READING PA 19605
K904317 AVALON TECHNOLOGY CORP. 9174 CASTLEGATE DR.
INDIANAPOLIS IN 46256 1004
K811615 BACH-SIMPSON LTD.
K811616 BACH-SIMPSON LTD.
K013803 BIOSONIX LTD. BEIT HAPA'AMON (BOX 124)
KFAR SABA 44425
K862841 BIOSOUND, INC. 7990 CASTLEWAY DR.
INDIANAPOLIS IN 46250
K840169 BIOTRONICS INSTRUMENTS 12020 W. RIPLEY AVENUE
WAUWATOSA WI 53226
K925524 CARDIOMETRICS, INC. 645 CLYDE AVE.
MOUNTAIN VIEW CA 94043
K905411 CARDIOMETRICS, INC. 645 CLYDE AVE.
MOUNTAIN VIEW CA 94043
K882593 CARDIOMETRICS, INC. 645 CLYDE AVE.
MOUNTAIN VIEW CA 94043
K901733 CARDIOMETRICS, INC. 645 CLYDE AVE.
MOUNTAIN VIEW CA 94043
K041180 CARDIOSONIX, LTD. BEIT HAPA'AMON (BOX 124)
KFAR SABA 44425
K023431 CARDIOSONIX, LTD. BEIT HAPA'AMON (BOX 124)
KFAR SABA 44425
K030357 CARDIOSONIX, LTD. BEIT HAPA'AMON (BOX 124)
KFAR SABA 44425
K820272 CAROLINA MEDICAL ELECTRONICS
K810561 CAROLINA MEDICAL ELECTRONICS
K110347 COOK VASCULAR, INC. 1186 MONTGOMERY LANE
VANDERGRIFT PA 15690
K051145 CRITISENSE LTD. 6329 W. WATERVIEW CT.
MCCORDSVILLE IN 46055-9501
K062977 CRITISENSE LTD. 3460 POINTE CREEK CT.
BONITA SPRINGS FL 34134-2015
K761288 D. EUGENE HOKANSON
K031706 DELTEX MEDICAL TERMINUS RD.
CHICHESTER, WEST SUSSEX PO19 8TX
K951369 DELTEX MEDICAL 15825 SHADY GROVE RD.
ROCKVILLE MD 20850
K111542 DELTEX MEDICAL LIMITED BIOPARK, BROADWATER ROAD
HERTSFORDSHIRE AL7 3AX
K132139 DELTEX MEDICAL LIMITED 11440 W. BERNARDO CT.
SAN DIEGO CA 92127
K172457 Deltex Medical Limited Terminus Road
Chichester PO19 8TX
K150347 DELTEX MEDICAL LIMITED TERMINUS RD.
CHICHESTER PO19 8TX
K861023 DIAGNOSTIC ELECTRONICS CORP. BOX 580
LEXINGTON MA 02173
K860651 DIAGNOSTIC ELECTRONICS CORP. BOX 580
LEXINGTON MA 02173
K904792 DIAGNOSTIC ULTRASOUND CORP. P.O. BOX 0789
KIRKLAND WA 98083 0789
K791418 DIAGNOSTICS INTL.
K040909 EM-TEC GMBH LERCHENBERG 20
FINNING 86923
K111730 EM-TEC GMBH LERCHENBERG 20
FINNING 86923
K901335 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH
WALLINGFORD CT 06492
K871490 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH
WALLINGFORD CT 06492
K013376 HEMEDEX INCORPORATED 7 TIFFANY TRAIL
HOPKINTON MA 01748
K913827 HEWLETT-PACKARD CO. 3000 MINUTEMAN RD.
ANDOVER MA 01810 1085
K902088 HEWLETT-PACKARD CO. 3000 MINUTEMAN RD.
ANDOVER MA 01810 1085
K002186 HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY
EATONTOWN NJ 07724-3327
K896613 IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR.
GOLDEN CO 80403
K882138 IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR.
GOLDEN CO 80403
K910049 INTERSPEC, INC. 110 WEST BUTLER AVE.
AMBLER PA 19002
K811246 IREX CORP.
K984338 JOSTRA BENTLEY 478 MEDIA RD.
OXFORD PA 19363
K892707 KOVEN AND ASSOC., INC. THE TRADE CENTER
ST. LOUIS MO 63042
K903026 KOVEN AND ASSOC., INC. THE TRADE CENTER
ST. LOUIS MO 63042
K915550 KOVEN AND ASSOC., INC. THE TRADE CENTER
ST. LOUIS MO 63042
K922669 KOVEN AND ASSOC., INC. THE TRADE CENTER
ST. LOUIS MO 63042
K920333 KOVEN AND ASSOC., INC. THE TRADE CENTER
ST. LOUIS MO 63042
K010452 KOVEN TECHNOLOGY, INC. 11874 SOUTH EVELYN CIRCLE
HOUSTON TX 77071-3404
K954397 KOVEN TECHNOLOGY, INC. 300 BROOKES DR.
ST. LOUIS MO 63042
K031931 KOVEN TECHNOLOGY, INC. 11874 SOUTH EVELYN CIRCLE
HOUSTON TX 77071-3404
K942613 KOVEN TECHNOLOGY, INC. 300 BROOKES DR.
ST. LOUIS MO 63042
K050601 KOVEN TECHNOLOGY, INC. 11874 SOUTH EVELYN CIRCLE
HOUSTON TX 77071-3404
K982986 KOVEN TECHNOLOGY, INC. 300 BROOKES DR.
ST. LOUIS MO 63042
K874885 LAWRENCE MEDICAL SYSTEMS, INC. 1100 AVENIDA ACASO
CAMMARILLO CA 93010
K920844 LISCA DEVELOPMENT AB LOVSBERGSV. 13
LINKOPING
K840522 LITTON MEDICAL ELECTRONICS 777 NICHOLAS BLVD.
ELK GROVE VILLAGE IL 60007
K930227 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR.
OAKLAND NJ 07436
K844631 MEDEX, INC. 3637 LACON RD.
HILLARD OH 43026
K040228 MEDI-STIM A/S 7601 NORTHLAND DRIVE
BROOKLYN PARK MN 55428
K102595 MEDI-STIM ASA 435 RICE CREEK TERRACE NE
FRIDLEY MN 55432
K770115 MEDICAL ELECTRONIC DEVICES, INC.
K801802 MEDICAL TESTING SYSTEM, INC.
K973198 MEDICARD LTD. 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K854500 MEDPACIFIC CORP. 6701 SIXTH AVENUE SOUTH
SEATTLE WA 98108
K760751 MEDSONICS
K780302 MEDTRONIC VASCULAR
K853952 METRIFLOW, INC. 8702 WATERTOWN PLANK RD.
MILWAUKEE WI 53226
K970211 MICRO WEISS ELECTRONICS 55 NORTHERN BLVD. SUITE 410
GREAT NECK NY 11021
K970139 MICRO WEISS ELECTRONICS 55 NORTHERN BLVD. SUITE 410
GREAT NECK NY 11021
K860766 MILLAR INSTRUMENTS, INC. P.O. BOX 18227
HOUSTON TX 77223
K102433 MOOR INSTRUMENTS LTD. MILLWEY
AXMINSTER, DEVON EX135HU
K811376 NARCO BIO-SYSTEMS
K050088 NEOPROBE CORP. 425 METRO PLACE NORTH,
DUBLIN OH 43017
K820742 NIHON KOHDEN AMERICA, INC. 90 ICON ST.
FOOTHILL RANCH CA 92610 1601
K894631 NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE.
IRVINE CA 92714
K812005 NUCLEAR PACIFIC, INC.
K040654 OPTICAL SENSORS, INC. 800 LENANGER LN.
STOUGHTON WI 53589
K131854 OR-NIM MEDICAL LTD. 15 ATIR YEDA ST.
KFAR SABA 4464312
K150268 OR-NIM MEDICAL LTD. 15 ATIR YEDA ST.
KFAR SABA 4464312
K152930 PERIMED AB DATAVAGEN 9A
JARFALLA 17543
K011899 PERIMED AB DATAVAGEN 9-A
JARFALLA S-175 26
K890828 PERIMED, INC. 800 CENTENNIAL AVE.
PISCATAWAY NJ 08855 1327
K922368 PERIMED, INC. 200 CENTENNIAL AVE.
PISCATAWAY NJ 08854 3910
K974285 PERIMED, INC. 821 WEST JERICHO TURNPIKE
SMITHTOWN NY 11787
K932068 PERIMED, INC. 200 CENTENNIAL AVE.
PISCATAWAY NJ 08854 3910
K903625 PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD.
MOUNTAIN VIEW CA 94043
K992387 ROSSMAX INTERNATIONAL LTD. 2F. NO. 10, ALLEY 20 LANE 106
TAIPEI
K992388 ROSSMAX INTERNATIONAL LTD. 2F. NO. 10, ALLEY 20 LANE 106
TAIPEI
K973078 SEIN ELECTRONICS CO., LTD. ONE LETHBRIDGE PLAZA
MAHWAH NJ 07430-2113
K972798 SOMETEC, INC. 92 MONTVALE AVE., SUITE 3150
STONEHAM MA 02180
K862720 SONICAID, INC. P.O. BOX 588
FREDERICKSBURG VA 22401
K800151 SYVA CO.
K850137 TECA, INC. THREE CAMPUS DR.
PLEASANTIVILLE NY 10570
K030505 TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD.
ELKTON MD 21921
K922034 TITRONICS MEDICAL INSTRUMENTS, INC. P.O. BOX 2202
IOWA CITY IA 52244
K033424 TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD.
ITHACA NY 14850
K112657 TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD.
ITHACA NY 14850
K872048 TRANSONIC SYSTEMS, INC. CORNELL RESEARCH PARK
ITHACA NY 14850
K140740 TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD.
ITHACA NY 14850
K903633 TRANSTRACHEAL SYSTEMS WARREN RD. BUSINESS PARK
ITHACA NY 14850
K851057 TSI, INC. 500 CARDIGAN RD.
ST. PAUL MN 55112
K896515 TSI, INC. 6470 RIVERVIEW TERRACE
MINNEAPOLIS MN 55432
K864259 TSI, INC. 500 CARDIGAN RD.
ST. PAUL MN 55112
K875179 TSI, INC. 500 CARDIGAN RD.
ST. PAUL MN 55112
K110438 VASAMED, INC. 800 LEVANGER LANE
STOUGHTON WI 53589
K911763 VASAMEDICS, L.L.C. C/O C.G. BUNDY ASSOCIATES
MINNEAPOLIS MN 55432
K951486 VASAMEDICS, L.L.C. 2963 YORKTON BLVD.
SAINT PAUL MN 55117 1064
K912446 VASAMEDICS, L.L.C. C/O C.G. BUNDY ASSOCIATES
MINNEAPOLIS MN 55432
K052209 VASCULAR CONTROL SYSTEMS, INC 32236 PASEO ADELANTO, STE. F
SAN JUAN CAPISTRANO CA 92675
K031091 VASCULAR TECHNOLOGY INCORPORATED 175 CABOT ST.
LOWELL MA 01854
K082870 VASCULAR TECHNOLOGY INCORPORATED 12 MURPHY DR.
NASHUA NH 03062
K992529 VITAL MEDICAL LTD. 815 CONNECTICUT AVE., N.W.
WASHINGTON DC 20006-4004
K863210 WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W.
ROCHESTER MN 55903 6117
K901015 WRIGHT MEDICAL CORP. 11023 118TH PLACE N.E.
KIRKLAND WA 98033
K821373 XOMED, INC. 1318 LONEDELL RD.
ARNOLD MO 63010
K921377 ZERTL MEDICAL, INC. 7 KNOX COURT
LAWRENCEVILLE NJ 08648




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