FDA 510(k) Applications for Medical Device:
Dc-Defibrillator, Low-Energy, (Including Paddles)

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K011461 ACCESS CARDIOSYSTEMS, INC. 150 BAKER AVENUE EXTENSION
CONCORD MA 01742
K982896 ALEXANDER MFG. CO. 1511 S GARFIELD PL
MASON CITY IA 50401
K874697 ALTERNATIVE DESIGN SYSTEMS, INC. 419 HACKENSACK AVE.
CARLSTADT NJ 07072
K832827 AUTOMATED MEDICAL PRODUCTS, INC.
K891122 BIG VALLEY MEDICAL P.O. BOX 1892
ORANGEVALE CA 95662
K844103 BIRTCHER CORP. 4501 N. ARDEN DR.
EL MONTE CA 91731
K852799 CARDIAC RECORDERS, LTD. 34 SCARBOROUGH RD.
LONDON
K852905 CARDIAC RECORDERS, LTD. 34 SCARBOROUGH RD.
LONDON
K852808 CARDIAC RECORDERS, LTD. 34 SCARBOROUGH RD.
LONDON
K103334 CARDIO MEDICAL PRODUCTS, INC. 385 FRANKLIN AVE. STE. L
ROCKAWAY NJ 07866
K103159 CARDIO MEDICAL PRODUCTS, INC. 385 FRANKLIN AVE. STE. L
ROCKAWAY NJ 07866
K103651 CARDIO MEDICAL PRODUCTS, INC. 385 FRANKLIN AVE. STE. L
ROCKAWAY NJ 07866
K964469 CARDIOTRONICS SYSTEMS, INC. 5966 LA PLACE CT.
CARLSBAD CA 92008
K895113 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K922172 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K922173 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K911455 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K911456 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K921606 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K904462 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K922227 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K904466 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K923297 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K911402 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K882337 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K912621 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K920086 CARDIOTRONICS, INC. 2726 LOKER AVE.
WEST CARLSBAD CA 92008
K882235 CARDIOVASCULAR GROUP, INC. POST OFFICE BOX 1954
LAKE OSWEGO OR 97034
K855082 CONMED CORP. 310 BROAD ST.
UTICA NY 13501 1203
K811638 DATASCOPE CORP.
K844447 DATASCOPE CORP. 580 WINTERS AVE.
PARAMUS NJ 07653
K103783 FIAB S.P.A. VIA COSTOLI, 4
VICCHIO FLORENCE 50039
K895185 FIRST MEDICAL DEVICES CORP. 2445 140TH AVE NE STE 150
BELLEVUE WA 98005
K871136 FIRST MEDICAL DEVICES CORP. 2445 140TH AVE NE STE 150
BELLEVUE WA 98005
K871135 FIRST MEDICAL DEVICES CORP. 2445 140TH AVE NE STE 150
BELLEVUE WA 98005
K903657 FIRST MEDICAL DEVICES CORP. 11810 115TH AVE. NE
KIRKLAND WA 98034
K850618 FUKUDA DENSHI USA, INC. 12539 130TH LN. NE
KIRKLAND WA 98034
K150349 FULL POWER AED 707 East Hudson Ave
Durham NC 27704
K081442 HEART SYNC LLC 5643 PLYMOUTH ROAD
ANN ARBOR MI 48105
K951110 HELLIGE GMBH HEINRICH VON STEPHAN STRABE4
D7800 FREIBURG IM BREISGA
K812317 HEWLETT-PACKARD CO.
K910754 HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST.
MCMINNVILLE OR 97128
K853439 HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST.
MCMINNVILLE OR 97128
K823268 HEWLETT-PACKARD CO.
K844740 HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST.
MCMINNVILLE OR 97128
K893403 HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST.
MCMINNVILLE OR 97128
K840167 HONEYWELL, INC.
K831696 HONEYWELL, INC.
K851092 HONEYWELL, INC. ONE CAMPUS DR.
PLEASANTVILLE NY 10570
K810237 HONEYWELL, INC.
K781678 IPCO CORP.
K780416 IPCO CORP.
K812586 KANTRON CARDIOVASCULAR, INC.
K895662 KATECHO, INC. 2601 BELL AVE.
DES MOINES IA 50315
K912587 KATECHO, INC. 2601 BELL AVE.
DES MOINES IA 50315
K863899 KATECHO, INC. 2601 BELL AVE.
DES MOINES IA 50315
K935083 KATECHO, INC. 2500 BELL AVE.
DES MOINES IA 50321
K853354 KONE INSTRUMENTS, INC. BURDICK DIVISION
MILTON WI 53563
K854307 KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST.
EVERETT MA 02149
K885186 LAERDAL MFG. CORP. 12244 S.W. GARDEN PLACE
PORTLAND OR 97223
K900169 LAERDAL MFG. CORP. 12244 S.W. GARDEN PLACE
PORTLAND OR 97223
K902429 LAERDAL MFG. CORP. 12244 S.W. GARDEN PLACE
PORTLAND OR 97223
K812519 LIFE SCIENCE INSTRUMENTATION, INC.
K812520 LIFE SCIENCE INSTRUMENTATION, INC.
K831056 LIFE SCIENCE INSTRUMENTATION, INC.
K843396 LIFE SCIENCE INSTRUMENTATION, INC. 10150 SW NIMBUS AVE E-7
PORTLAND OR 97223
K840246 LIFE SCIENCE INSTRUMENTATION, INC.
K822294 LIFE SCIENCE INSTRUMENTATION, INC.
K822617 LIFE SCIENCE INSTRUMENTATION, INC.
K842235 LITTON DATAMEDIX
K842312 LITTON DATAMEDIX
K962551 MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE.
MILWAUKEE WI 53223
K842667 MARQUETTE ELECTRONICS, INC. P.O. BOX 9100
JUPITER FL 33468
K895651 MARQUETTE ELECTRONICS, INC. 8 BALLO DRIVE, BALLOO INDUS.
N. IRELAND BT19 2QY
K911662 MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE.
MILWAUKEE WI 53223
K921487 MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE.
MILWAUKEE WI 53223
K902782 MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE.
MILWAUKEE WI 53223
K902590 MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE.
MILWAUKEE WI 53223
K895533 MATRIX MEDICA, INC. 145 MID COUNTY DR.
ORCHARD PARK NY
K874091 MEDAC, INC. 7451 SW COHO CT.
TUALATIN OR 97062
K911665 MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST.
ARLETA CA 91331
K914458 MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST.
ARLETA CA 91331
K874204 MEDICAL RESEARCH LABORATORIES, INC. 6457 W. HOWARD ST.
NILES IL 60648
K952085 MEDICAL RESEARCH LABORATORIES, INC. 1000 ASBURY DR. NO.17
BUFFALO GROVE IL 60089
K930548 MEDICAL RESEARCH LABORATORIES, INC. 1000 ASBURY DR. NO.17
BUFFALO GROVE IL 60089
K840900 MEDICAL RESEARCH LABORATORIES, INC.
K833751 MEDICAL RESEARCH LABORATORIES, INC.
K911604 MEDPHONE CORP. THE ATRIUM SUITE 210 EAST 80
PARAMUS NJ 07652
K864257 MEDPHONE CORP. C/O DICKSTEIN/SHAPIRO & MORIN
WASHINGTON DC 20037
K903018 MEDTRONIC ANDOVER MEDICAL, INC. 60 NEWARK ST.
HAVERHILL MA 01830
K012274 MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD NE
REDMOND WA 98073-9706
K921765 METRONIC ELECTRONIC GMBH 5215 TERRELL LN.
HAMPTON VA 23666
K801544 NARCO BIO-SYSTEMS
K813471 NARCO SCIENTIFIC
K822961 NARCO SCIENTIFIC
K941995 NATIONAL CUSTOM ENT., INC. 400 GATEWAY BLVD.
BURNSVILLE MN 55337 2559
K863404 NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE.
IRVINE CA 92714
K863405 NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE.
IRVINE CA 92714
K880575 NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE.
IRVINE CA 92714
K971194 NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR.
IRVINE CA 92612-1601
K971436 NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR.
IRVINE CA 92612-1601
K971355 NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR.
IRVINE CA 92612-1601
K840258 NIHON KOHDEN AMERICA, INC. 90 ICON ST.
FOOTHILL RANCH CA 92610 1601
K914971 NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE.
IRVINE CA 92714
K872793 NIKOMED U.S.A., INC. HILLSBORO BUSINESS CENTER
BELLE MEAD NJ 08502
K854175 ODAM 19, AVENUE DE LA GARE
WISSEMBOURG CEDEX
K823931 ODAM
K823933 ODAM SIEGE SOCIAL
FRANCE
K893990 PACE WEST P.O. BOX 297
FAIRFIELD CA 94533
K895009 PADECO, INC. P.O. BOX 2106
LAKE OSWEGO OR 97035
K030417 PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD.
ANDOVER MA 01810-1099
K894355 PHYCON 635 GILLETTE AVE.
TAMPA FL 33617
K894356 PHYCON 635 GILLETTE AVE.
TAMPA FL 33617
K910144 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K871224 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K890079 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K931053 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K843229 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K902478 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K883617 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K842624 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K905510 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K881153 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K935674 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K895379 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K902288 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K912966 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K832833 PHYSIO-CONTROL CORP.
K922315 PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E.
REDMOND WA 98073 9706
K182503 Physio-Control, Inc. 11811 Willow Road NE
Redmond WA 98052
K923864 PORTABLE POWER SYSTEMS, INC. 1940 TEE LN.
CASTLE ROCK CO 80104
K931266 PORTABLE POWER SYSTEMS, INC. 1940 TEE LN.
CASTLE ROCK CO 80104
K934508 PORTABLE POWER SYSTEMS, INC. 1940 TEE LN.
CASTLE ROCK CO 80104
K934015 PORTABLE POWER SYSTEMS, INC. 10336 SOUTH DRANSFELDT RD.
PARKER CO 80134
K921666 PPG HELLIGE B.V. P.O. BOX 15955
LENEXA KS 66285 5955
K863303 QUINTON, INC. 2121 TERRY AVE.
SEATLE WA 98121
K800936 R2 CORP.
K800937 R2 CORP.
K922563 RACO PRODUCTS CO. 5504 STATE RD.
CLEVELAND OH 44134
K920990 RACO PRODUCTS CO. 5504 STATE RD.
CLEVELAND OH 44134
K200849 Remote Diagnostic Technologies, Ltd, a Philips Company Pavilion C2, Ashwood Park, Ashwood Way
Basingstoke RG23 8BG
K851485 ROBERT BOSCH CORP. FLOWER FIELD BLDG. #17
ST. JAMES NY 11780
K851931 S & W MEDICO TEKNIK 1819 H. ST. NW
WASHINGTON DC 20006
K910634 SIEMENS BURDICK, INC. 15 PLUMB ST.
MILTOON WI 53563
K823828 SIEMENS MEDICAL SOLUTIONS USA, INC.
K905065 SPACELABS, INC. 15220 N.E. 40TH ST.
REDMOND WA 98073 9713
K896903 SPACELABS, INC. 15220 N.E. 40TH ST.
REDMOND WA 98073 9713
K970481 SURVIVALINK CORP. 5420 FELTL RD.
MINNEAPOLIS MN 55343
K851924 TEMTECH LTD. 8 BALLOO DR.
BANGOT,CO. DOWN BT192QY ND
K993205 TZ MEDICAL, INC. 15858 S.W. UPPER BOONES FERRY
LAKE OSWEGO OR 97035
K940842 UNIPOWER CORP. 1216 W. 96TH ST.
MINNEAPOLIS MN 55431
K935111 UNIPOWER CORP. 1216 W. 96TH ST.
MINNEAPOLIS MN 55431
K913484 ZMI CORP. 500 WEST CUMMINGS PARK
WOBURN MA 01801
K895032 ZMI CORP. 500 WEST CUMMINGS PARK
WOBURN MA 01801
K931803 ZOLL MEDICAL CORP. 32 SECOND AVE.
BURLINGTON MA 01803
K032691 ZOLL MEDICAL CORP. 269 MILL ROAD
CHELMSFORD MA 01824-4105
K963781 ZOLL MEDICAL CORP. 32 SECOND AVE.
BURLINGTON MA 01803
K042302 ZOLL MEDICAL CORP. 269 MILL ROAD
CHELMSFORD MA 01824-4105
K931804 ZOLL MEDICAL CORP. 32 SECOND AVE.
BURLINGTON MA 01803
K931805 ZOLL MEDICAL CORP. 32 SECOND AVE.
BURLINGTON MA 01803
K931787 ZOLL MEDICAL CORP. 500 WEST CUMMINGS PARK
WOBURN MA 01801
K140502 ZOLL MEDICAL CORPORATION 269 MILL ROAD
CHELMSFORD MA 01824-4105
K081574 ZOLL MEDICAL CORPORATION 269 MILL ROAD
CHELMSFORD MA 01824
K100654 ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD
CHELMSFORD MA 01824-4105
K102468 ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD
CHELMSFORD MA 01824-4105




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