FDA 510(k) Applications for Medical Device:
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K131506 | ABEON MEDICAL CORPORATION |
8000 KATHERINE BOULEVARD | BRECKSVILLE | OH | 44141 |
| K142467 | ABEON MEDICAL CORPORATION |
8000 KATHERINE BOULEVARD | BRECKSVILLE | OH | 44141 |
| K031741 | ALARIS MEDICAL SYSTEMS, INC. |
10221 WATERIDGE CIR. | SAN DIEGO | CA | 92121 |
| K991086 | BCI INTL., INC. |
N7 W22025 JOHNSON RD. | WAUKESHA | WI | 53186 |
| K970209 | BCI INTL., INC. |
W238 N1650 ROCKWOOD DR. | WAUKESHA | WI | 53188 |
| K030407 | BCI, INC. |
N7 W22025 JOHNSON RD. | WAUKESHA | WI | 53186 |
| K192446 | Beijing Kingst Commercial & Trade Co.,Ltd. |
6th Floor of No.2-7,Road Beibinhe | Beijing | 100053 | |
| K192488 | Beijing Kingst Commercial & Trade Co.,Ltd. |
6th Floor of No.2-7,Road Beibinhe | Beijing | 100053 | |
| K143150 | BESMED HEALTH BUSINESS CORP. |
NO.5, LANE116, WU-KONG 2ND RD | NEW TAIPEI CITY | TAIWAN | |
| K190824 | Bluepoint Medical GmbH & Co. KG |
An der Trave 15 | Selmsdorf | 23923 | |
| K000520 | BREGAS AB |
ULVSUNDAVAGEN 178B | BROMMA | SE-16867 | |
| K023820 | BREGAS AB |
ULVSUNDAVAGEN 178B | BROMMA | SE-16867 | |
| K120518 | CAREFUSION |
1500 WAUKEGAN ROAD | WAUKEGAN | IL | 60085 |
| K170820 | CMI Health Inc. |
5975 Shiloh Road, Suite 114 | Alpharetta | GA | 30005 |
| K203762 | Covidien |
6135 Gunbarrel Ave | Boulder | CO | 80301 |
| K213518 | Covidien llc |
6135 Gunbarrel Ave | Boulder | CO | 80301 |
| K213911 | Covidien LLC |
6135 Gunbarrel Ave | Boulder | CO | 80301 |
| K980384 | DATEX-ENGSTROM, INC. |
2 HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
| K001814 | DATEX-OHMEDA |
THREE HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
| K023454 | DATEX-OHMEDA |
86 PILGRIM RD. | NEEDHAM | MA | 02492 |
| K993656 | DATEX-OHMEDA, INC. |
3 HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
| K143127 | DISPO-MED (MALAYSIA) SDN BHD |
21, JALAN TEKNOLOGI 3/5A, PUSAT TEKNOLOGI SINAR DAMANSARA, | PETALING JAYA , SELANGOR DARUL EHSAN | 47810 | |
| K100941 | DRAEGER MEDICAL AG & CO. KG |
53/55 MOISLINGER ALLEE | LUEBECK | D-23542 | |
| K053204 | DRAEGER MEDICAL AG & CO. KGAA |
3155 QUARRY ROAD | TELFORD | PA | 18969 |
| K040847 | DRAEGER MEDICAL, INC. |
3135 QUARRY RD. | TELFORD | PA | 18969 |
| K012139 | DRAEGER MEDICAL, INC. |
3135 QUARRY RD. | TELFORD | PA | 18969 |
| K221118 | Draegerwerk AG & Co. KGaA |
53/55 Moislinger Allee | Luebeck | 23542 | |
| K041956 | DRAEGET MEDICAL AG & CO. KGAA |
3135 Quarry Road | Telford | PA | 18969 |
| K213767 | Endure Industries Inc |
45 N Fulton St | Homer | NY | 13077 |
| K220533 | Engineered Medical Systems Inc. |
2055 Executive Dr | Indianapolis | IN | 46241 |
| K133516 | FLEXICARE |
CYNON VALLEY BUSINESS PARK | MID GLAM | CF454ER | |
| K140473 | FLEXICARE MEDICAL LTD. |
CYNON VALLEY BUSINESS PARK | MID GLAMORGAN | CF45 4ER | |
| K140113 | FLEXICARE MEDICAL LTD. |
CYNON VALLEY BUSINESS PARK | MID GLAMORGAN | CF45 4ER | |
| K980979 | FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C | REDMOND | WA | 98052-4911 |
| K052880 | GE HEALTHCARE |
86 PILGRIM ROAD | NEEDHAM | MA | 02492 |
| K052582 | GE HEALTHCARE |
86 PILGRIM ROAD | NEEDHAM | MA | 02492 |
| K052167 | GE HEALTHCARE |
86 PILGRIM ROAD | NEEDHAM | MA | 02492 |
| K211171 | GE Healthcare Finland Oy |
Kuortaneenkatu 2 | Helsinki | FI-00510 | |
| K183394 | GE Healthcare Finland Oy |
Kuortaneenkatu 2 | Helsinki | FI-00510 | |
| K150245 | GE HEALTHCARE FINLAND OY |
KUORTANEENKATU 2 | HELSINKI | FIN-00510 | |
| K171028 | GE Healthcare Finland OY |
Kuortaneenkatu 2 | Helsinki | FI-00510 | |
| K961150 | HUDSON RESPIRATORY CARE, INC. |
27711 DIAZ RD. | TEMECULA | CA | 92390-0740 |
| K954402 | ICOR AB |
ULVSUNDAVAGEN 178 B | BROMMA | 161 30 | |
| K962638 | INSTRUMENTARIUM CORP. |
2 HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
| K122075 | INTERSURGICAL, INC. |
417 ELECTRONICS PKWY. | LIVERPOOL | NY | 13088 |
| K964961 | IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. | BRANFORD | CT | 06405 |
| K983114 | MAGNA ADVANCED TECHNOLOGIES, INC. |
7200 N.W. SEVENTH ST. | MIAMI | FL | 33126 |
| K982846 | MAGNA ADVANCED TECHNOLOGIES, INC. |
7200 N.W. SEVENTH ST. | MIAMI | FL | 33126 |
| K954120 | MAGNETIC RESONANCE EQUIPMENT CORP. |
5 GRANT AVE. | BAY SHORE | NY | 11706 |
| K003982 | MAGNETIC RESONANCE EQUIPMENT CORP. |
6 WASHINGTON AVE. | BAY SHORE | NY | 11706 |
| K050066 | MARQUEST MEDICAL PRODUCTS, INC. |
11039 EAST LANSING CIR. | ENGLEWOOD | CO | 80112 |
| K960972 | MARQUEST MEDICAL PRODUCTS, INC. |
11039 EAST LANSING CIR. | ENGLEWOOD | CO | 80112 |
| K973984 | MARQUETTE MEDICAL SYSTEMS, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K201590 | Masimo Corporation |
52 Discovery | Irvine | CA | 92618 |
| K133540 | MAXTEC, INC. |
6526 SOUTH COTTONWOOD ST. | SALT LAKE CITY | UT | 84107 |
| K182362 | Maxtec, LLC |
2305 S 1070 W | Salt Lake City | UT | 84119 |
| K000712 | MEDICAL RESEARCH LABORATORIES, INC. |
1000 ASBURY DR. NO.17 | BUFFALO GROVE | IL | 60089 |
| K180902 | MediPines Corporation |
155 N Riverview Drive | Anaheim | CA | 92808 |
| K131339 | MEDIPLUS LTD. |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K192563 | Meditera Tibbi Malzeme San. ve Tic. A.S. |
Ibni Melek OSB Mah. TOSBI Yol 4 Sok | Izmir | 35900 | |
| K971229 | MEDSYS, INC. |
377 ROUTE 17 SOUTH | HASBROUCK HEIGHTS | NJ | 07604 |
| K983864 | MENNEN MEDICAL, INC. |
KIRYAT WEIZMANN SCIENCE PARK | REHOVOT | 76100 | |
| K021576 | MERCURY MEDICAL |
11300 49TH ST. NORTH | CLEARWATER | FL | 33762-4800 |
| K031411 | MERCURY MEDICAL |
11300 49TH ST. NORTH | CLEARWATER | FL | 33762-4800 |
| K083056 | MERCURY MEDICAL |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K031814 | MERCURY MEDICAL |
11300 49TH ST. NORTH | CLEARWATER | FL | 33762-4800 |
| K133806 | MONITOR MASK, INC. |
816 CONGRESS AVENUE, SUITE 1400 | AUSTIN | TX | 78701 |
| K040875 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K062115 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K020046 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K083456 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K964305 | NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. | IRVINE | CA | 92612-1601 |
| K990063 | NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. | IRVINE | CA | 92612-1601 |
| K072843 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K110594 | NIHON KOHDEN CORP. |
90 ICON STREET | FOOTHILL RANCH | CA | 92610 |
| K122214 | NIHON KOHDEN CORP. |
90 ICON STREET | FOOTHILL RANCH | CA | 92610 |
| K171765 | Nihon Kohden Corporation |
1-31-4 Nishiochiai, Shinjuku-Ku | Tokyo | 161-8560 | |
| K161860 | NIHON KOHDEN CORPORATION |
1-31-4 NISHIOCHIAI, SHINJUKU-KU | TOKYO | 161-8560 | |
| K982969 | NONIN MEDICAL, INC. |
2605 FERNBROOK LANE, NORTH | MINNEAPOLIS | MN | 55447-4755 |
| K963327 | NOVAMETRIX MEDICAL SYSTEMS, INC. |
1 BARNES INDUSTRIAL PARK RD. | WALLINGFORD | CT | 06492 |
| K984579 | OPTICAL SENSORS, INC. |
7615 GOLDEN TRIANGLE DR., | EDEN PRAIRIE | MN | 55344 |
| K010795 | OPTICAL SENSORS, INC. |
800 LENANGER LN. | STOUGHTON | WI | 53589 |
| K171828 | Orantech Inc. |
Zone#A,4F,1st Bld, 7th Industrial Zone | Shenzhen | 518106 | |
| K094012 | ORIDION CAPNOGRAPHY, INC. |
160 GOULD STREET | NEEDHAM | MA | 02494 |
| K040011 | ORIDION LTD. |
21 HIGHLAND CIRCLE | NEEDHAM | MA | 02494-3038 |
| K150272 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. | JERUSALEM | 9777407 | |
| K200594 | Oridion Medical 1987 Ltd. |
7 Hamarpe St. | Jerusalem | 9777407 | |
| K112368 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE STREET, HAR | JERUSALEM | 91450 | |
| K123690 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. | JERUSALEM | 91450 | |
| K012395 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O. BOX 45025 | JERUSALEM | 91450 | |
| K012391 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O. BOX 45025 | JERUSALEM | 91450 | |
| K181624 | Oridion Medical 1987 Ltd. |
7 Hamarpe Street, P.O. Box 45025 | Jerusalem | 9777407 | |
| K002163 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O.B. 45025 | JERUSALEM | 91450 | |
| K121927 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O. BOX 45025 | JERUSALEM | 91450 | |
| K181467 | Oridion Medical 1987 Ltd. |
7 Hamarpe Street P.O. Box 45025 | Jerusalem | 9777407 | |
| K011536 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O. BOX 45025 | JERUSALEM | 91450 | |
| K011050 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O. BOX 45025 | JERUSALEM | 91450 | |
| K013845 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O. BOX 45025 | JERUSALEM | 91450 | |
| K010024 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O. BOX 45025 | JERUSALEM | 91450 | |
| K012394 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O. BOX 45025 | JERUSALEM | 91450 | |
| K042665 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O. BOX 45025 | JERUSALEM | 91450 | |
| K093388 | ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O.B. 45025 | JERUSALEM | 91450 | |
| K981114 | ORIDION MEDICAL LTD. |
7 HAMARPE ST. | JERUSALEM | 91450 | |
| K980324 | ORIDION MEDICAL LTD. |
P.O. BOX 45025 | JERUSALEM | 91450 | |
| K980327 | ORIDION MEDICAL LTD. |
P.O. BOX 45025 | JERUSALEM | 91450 | |
| K980325 | ORIDION MEDICAL LTD. |
P.O. BOX 45025 | JERUSALEM | 91450 | |
| K072813 | PHASEIN AB |
4213 WINNEQUAH DR. | MADISON | WI | 53716 |
| K063167 | PHASEIN AB |
4213 WINNEQUAH DR. | MADISON | WI | 53716 |
| K123043 | PHASEIN AB |
404 WILLIAMSON ST. | MADISON | WI | 53703 |
| K103604 | PHASEIN AB |
4213 WINNEQUAH DR. | MADISON | WI | 53716 |
| K081601 | PHASEIN AB |
4213 WINNEQUAH DR. | MADISON | WI | 53716 |
| K172904 | Philips Medizin Systeme Boeblingen GmbH |
Hewlett-Packard-Str.-2 | Boeblingen | 71034 | |
| K210112 | Pneuma Therapeutics, Inc. |
4090 E Bujia Primera | Tucson | AZ | 85718-6164 |
| K172365 | Pom Medical, LLC |
1230 Madera Rd., Suite 5, Box 101 | Simi Valley | CA | 92065 |
| K053063 | PRO-TECH SERVICES, INC. |
4338 HARBOUR POINTE BLVD. S.W. | MUKILTEO | WA | 98275 |
| K023579 | PROMEDIC, INC. |
6329 WEST WATERVIEW CT. | MCCORDSVILLE | IN | 46055-9501 |
| K171235 | Respirion, Inc. |
101 North Chestnut Street, Suite 209 | Winston-Salem | NC | 27101 |
| K053174 | RESPIRONICS NOVAMETRIX LLC |
5 TECHNOLOGY DRIVE | WALLINGFORD | CT | 06492 |
| K042601 | RESPIRONICS NOVAMETRIX, INC. |
5 TECHNOLOGY DR. | WALLINGFORD | CT | 06492 |
| K041450 | RESPIRONICS NOVAMETRIX, INC. |
5 TECHNOLOGY DR. | WALLINGFORD | CT | 06492 |
| K030886 | RESPIRONICS NOVAMETRIX, INC. |
5 TECHNOLOGY DR. | WALLINGFORD | CT | 06492 |
| K173147 | Revolutionary Medical Devices, Inc. |
4090 E. Bujia Primera | Tucson | AZ | 85718 |
| K151421 | Salter Labs |
2365 Camino Vida Roble | Carlsbad | CA | 92011 |
| K112840 | SEEBREATH AB |
MORKULLEVAGEN 31 | BJARRED | 23736 | |
| K003550 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K992116 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K954632 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K131410 | SOUTHMEDIC, INC. |
50 ALLIANCE BLVD., | BARRIE, ONTARIO | L4M 5K3 | |
| K014211 | SOUTHMEDIC, INC. |
6329 W. WATERVIEW CT. | MCCORDSVILLE | IN | 46051-9501 |
| K130112 | SPACELABS HEALTHCARE |
P.O. BOX 3018 | NEDERLAND | CO | 80466 |
| K121017 | SPACELABS HEALTHCARE |
P.O. BOX 3018 | NEDERLAND | CO | 80466 |
| K964239 | SPEGAS INDUSTRIES, LTD. |
70 WALNUT ST. | WELLESLEY | MA | 02181 |
| K132946 | Teleflex Medical, Inc. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K143469 | TELEFLEX MEDICAL, INC. |
2917 WECK DRIVE | RESEARCH TRIANGLE | NC | 27709 |
| K080527 | TRAWAX PTY LIMITED |
29662 AVANTE | LAGUNA NIGUEL | CA | 92677 |
| K181981 | Tylenol Medical Instruments Co., Ltd |
3rd Floor, No. 10, Xinhua Road, Sanjiao Town | Zhong Shan | 528445 | |
| K210019 | Unimed Medical Supplies, Inc. |
Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan | Shenzhen | 518108 | |
| K973544 | VACUMED, DIV. OF VACUMETRICS, INC. |
2225 EAST MURRAY HOLLADAY RD. | SALT LAKE CITY | UT | 84117 |
| K093525 | VENTLAB CORP. |
155 BOYCE DRIVE | MOCKSVILLE | NC | 27028 |
| K063813 | VENTLAB CORP. |
155 BOYCE DRIVE | MOCKSVILLE | NC | 27028 |
| K161250 | Venture Therapeutics, Inc. |
6525 Doubletree Avenue | Columbus | OH | 43229 |
| K171678 | Vyaire Medical, Inc. |
Kuortaneenkatu 2 | Helsinki | FIN-00510 | |
| K051857 | WEISSBURG ASSOCIATES |
4213 WINNEQUAH DRIVE | MADISON | WI | 53716 |
| K070128 | Westmed, Inc. |
5580 S. NOGALES HIGHWAY | TUCSON | AZ | 85706 |
| K072220 | Westmed, Inc. |
5580 S. NOGALES HIGHWAY | TUCSON | AZ | 85706 |
| K162343 | WESTMED, INC. |
5580 S NOGALES HWY | TUCSON | AZ | 85706 |
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