FDA 510(k) Applications for Medical Device:
Computer, Diagnostic, Pre-Programmed, Single-Function

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K021874 ABBOTT LABORATORIES 200 ABBOTT PARK RD.
ABBOTT PARK IL 60064-6157
K961661 ABBOTT LABORATORIES DEPT. 389, AP30
ABBOTT PARK IL 60064-3537
K970784 ALEXANDER MFG. CO. 1511 S GARFIELD PL
MASON CITY IA 50401
K092219 APPLIED PHYSIOLOGY PTY LTD. 13605 W. 7TH AVE.
GOLDEN CO 80401
K000664 BAXTER HEALTHCARE CORP. 17221 RED HILL AVE.
IRVINE CA 92614-5627
K132892 BOMED INC 59-440 PILI PL.
KAMUELA HI 96743
K122400 CARDIOX CORP. 4100 HORIZONS DRIVE, SUITE 100
COLUMBUS OH 43220
K101487 CHEETAH MEDICAL INC. 12154 DARNESTOWN RD. #236
GAITHERSBURG MD 20878
K042144 CHEETAH MEDICAL INC. MIZPE AVIV, INDUSTRIAL PARK 13
M.P. MISGAV 20187
K071631 CHEETAH MEDICAL INC. 12154 DARNESTOWN RD. #236
GAITHERSBURG MD 20878
K190955 Directed Systems Ltd St John's Innovation Centre, Cowley Road
Cambridge CB4 0WS
K212529 Directed Systems Ltd 47-51 Norfolk Street
Cambridge CB1 2LD
K073113 Draeger Medical Systems, Inc. 6 TECH DRIVE
ANDOVER MA 01810
K110597 EDWARDS LIFESCIENCES ONE EDWARDS WAY
IRVINE CA 92614
K193179 Edwards Lifesciences, LLC One Edwards Way
Irvine CA 92614
K131892 EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY
IRVINE CA 92614
K100709 EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY
IRVINE CA 92614
K060660 EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY
IRVINE CA 92614
K082308 EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY
IRVINE CA 92614
K040287 EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY
IRVINE CA 92614
K043103 EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY
IRVINE CA 92614
K103094 EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY
IRVINE CA 92614
K062134 EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY
IRVINE CA 92614
K131588 EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY
IRVINE CA 92614
K132528 GE HEALTHCARE FINLAND OY KUORTANEENKATU 2
HELSINKI FIN-00510
K962128 HEMO SAPIENS, INC. 19211 EDGEHILL DR.
IRVINE CA 92612-3505
K232048 ICU Medical 915 Calle Amanecer
San Clemente CA 92673
K152935 LIDCO LTD 16 ORSMAN ROAD
LONDON N1 5QJ
K163334 LiDCO Ltd 16 ORSMAN ROAD
LONDON N1 5QJ
K131048 LIDCO LTD. 16 ORSMAN RD.
LONDON N15QJ
K962918 LIDCO LTD. 16809 BRIARDALE RD.
ROCKVILLE MD 20850
K023960 LIDCO LTD. 16 ORSMAN RD.
LONDON N15QJ
K122247 LIDCO LTD. 16 ORSMAN RD.
LONDON N15QJ
K010049 LIDCO LTD. 16 ORSMAN RD.
LONDON N15QJ
K032997 MENNEN MEDICAL LTD. 4 HAYARDEN ST.
YAVNE 81228
K991775 MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK
REHOVOT 76100
K081776 OMEGA CRITICAL CARE LIMITED OMEGA HOUSE, 2 CAIRN COURT
EAST KILBRIDE G74 4NB
K060898 PULSION MEDICAL SYSTEMS AG P.O. BOX 99033
RALEIGH NC 27624
K072735 PULSION MEDICAL SYSTEMS AG 7220 SPARHAWK RD.
WAKE FOREST NC 27587
K091786 PULSION MEDICAL SYSTEMS AG 7220 SPARHAWK RD.
WAKE FOREST NC 27587
K172259 PULSION Medical Systems SE Hans-Riedl-Str. 17
Feldkirchen 85622
K122121 PULSION MEDICAL SYSTEMS SE 1511 ESSEX RD
WESTBROOK CT 06498
K192169 Pulsion Medical Systems SE Hans-Riedl-Str. 17
Feldkirchen 85622
K112448 PULSION MEDICAL SYSTEMS, INC. 1511 ESSEX RD
WESTBROOK CT 06498
K001762 PULSION MEDICAL SYSTEMS, INC. 20462-A CHARTWELL CENTER DR.
CORNELIUS NC 28031
K181372 Retia Medical, LLC 7 Dana Rd. Suite 111
Valhalla NY 10595
K113821 TRANSONIC SYSTEMS, INC. 34 Dutch Mill Rd
ITHACA NY 14850
K080116 TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD.
ITHACA NY 14850
K134051 TRANSONIC SYSTEMS, INC. 34 Dutch Mill Rd
ITHACA NY 14850
K140017 TRANSONIC SYSTEMS, INC. 34 Dutch Mill Rd
ITHACA NY 14850
K134035 TRANSONIC SYSTEMS, INC. 34 Dutch Mill Rd
ITHACA NY 14850
K955417 VITAL SIGNS, INC. 20 CAMPUS RD.
TOTOWA NJ 07512




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