FDA 510(k) Applications for Medical Device:
Humidifier, Respiratory Gas, (Direct Patient Interface)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K991484 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K041963 | AMERICAN BANTEX CORP. |
994 NORTH MAIN STREET | BOUNTIFUL | UT | 84010 |
| K062664 | APEX MEDICAL CORP. |
NO. 9, MINSHENG STREET | TUCHENG CITY, TAIPEI COUNTY | 236 | |
| K962079 | AUTOMATIC LIQUID PACKAGING, INC. |
2200 W. LAKE SHORE DR. | WOODSTOCK | IL | 60098 |
| K060790 | BREAS MEDICAL AB |
FORETAGSVAGEN 1 | MOLNLYCKE | SE 435 33 | |
| K090915 | CARDINAL HEALTH, INC. |
1430 WAUKEGAN ROAD- MPKB-2B | MCGAW PARK | IL | 60085 |
| K160764 | CAREFUSION 2200, INC. |
75 N. FAIRWAY DR. | VERNON HILLS | IL | 60061 |
| K102618 | DRAEGER MEDICAL AG & CO. KG |
3135 Quarry Road | Telford | PA | 18969 |
| K953392 | FISHER & PAYKEL ELECTRONICS LTD. |
25 CARBINE ROAD PANMURE | AUCKLAND, NEW ZEALAND | ||
| K162553 | FISHER & PAYKEL HEALTHCARE |
15 MAURICE PAYKEL PLACE, EAST TAMAKI | AUCKLAND | 2013 | |
| K220703 | Fisher & Paykel Healthcare |
15 Maurice Paykel Place | Auckland | 2013 | |
| K222292 | Fisher & Paykel Healthcare |
15 Maurice Paykel Place | Auckland | 2013 | |
| K223684 | Fisher & Paykel Healthcare Ltd |
15 Maurice Paykel Place, East Tamaki | Auckland | 2013 | |
| K212031 | Fisher & Paykel Healthcare Ltd |
15 Maurice Paykel Place, East Tamaki | Auckland | 2013 | |
| K191818 | Fisher & Paykel Healthcare Ltd |
15 Maurice Paykel Place, East Tamaki | Auckland | 2013 | |
| K234058 | Fisher & Paykel Healthcare Ltd |
15 Maurice Paykel Place, East Tamaki | Auckland | 2013 | |
| K222197 | Fisher & Paykel Healthcare Ltd |
15 Maurice Paykel Place, East Tamaki | Auckland | 2013 | |
| K233821 | Fisher & Paykel Healthcare Ltd |
15 Maurice Paykel Place, East Tamaki | Auckland | 2013 | |
| K231956 | Fisher & Paykel Healthcare Ltd |
15 Maurice Paykel Place, East Tamaki | Auckland | 2013 | |
| K143646 | Fisher & Paykel Healthcare Ltd |
15 Maurice Paykel Place, East Tamaki | Auckland | 2013 | |
| K251611 | Fisher & Paykel Healthcare Ltd |
15 Maurice Paykel Place, East Tamaki | Auckland | 2013 | |
| K201723 | Fisher & Paykel Healthcare Ltd. |
15 Maurice Paykel Place, East Tamaki | Auckland | 2013 | |
| K131895 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | EAST TAMAKI | 2013 | |
| K121975 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | ACKLAND | 2013 | |
| K092846 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | EAST TAMAKI, AUCKLAND | 2013 | |
| K132017 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | EAST TAMAKI | 2013 | |
| K131957 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | ACKLAND | 2013 | |
| K033710 | FISHER & PAYKEL HEALTHCARE, LTD. |
P.O BOX 14-348 | PANMURE, AUCKLAND | 1701 | |
| K110019 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | AUCKLAND | 1741 | |
| K100554 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | EAST TAMAKI | ||
| K983112 | FISHER & PAYKEL HEALTHCARE, LTD. |
HEALTHCARE DIV. | AUCKLAND | ||
| K003973 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | EAST TAMAKI | ||
| K020332 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | EAST TAMAKI | ||
| K073706 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | EAST TAMAKI | ||
| K211096 | Fisher &Paykel Healthcare Ltd. |
15 Maurice Paykel Place, East Tamaki | Auckland | 2013 | |
| K161314 | FLEXICARE MEDICAL LIMITED |
CYNON VALLEY BUSINESS PARK | MOUNTAIN ASH | CF45 4ER | |
| K133766 | GRUENDLER GMBH |
9001 SPECTRUM CENTER BLVD. | SAN DIEGO | CA | 92123 |
| K122705 | GRUNDLER GMBH |
9001 SPECTRUM CENTER BLVD | SAN DIEGO | CA | 92123 |
| K163283 | HAMILTON MEDICAL AG |
VIA CRUSCH 8 | BONADUZ | 7402 | |
| K152029 | HAMILTON MEDICAL AG |
VIA CRUSCH 8 | BONADUZ | 7402 | |
| K223551 | Hometa Inc |
300 Great Oaks Blvd, Suite 325 | Albany | NY | 12203 |
| K993773 | HUDSON RCJ AB |
6470 RIVERVIEW TERRACE | MINNEAPOLIS | MN | 55432 |
| K001213 | HUDSON RESPIRATORY CARE, INC. |
27711 DIAZ RD. | TEMECULA | CA | 92589-9020 |
| K993355 | HUDSON RESPIRATORY CARE, INC. |
27711 DIAZ RD. | TEMECULA | CA | 92589-9020 |
| K031383 | HUDSON RESPIRATORY CARE, INC. |
27711 DIAZ RD. | TEMECULA | CA | 92589-9020 |
| K010402 | HUDSON RESPIRATORY CARE, INC. |
27711 DIAZ RD. | TEMECULA | CA | 92589-9020 |
| K993282 | I.P.I. MEDICAL PRODUCTS |
3217 N. KILPATRICK AVE. | CHICAGO | IL | 60641 |
| K003561 | INVACARE CORP. |
ONE INVACARE WAY | ELYRIA | OH | 44036-2125 |
| K031176 | INVACARE CORP. |
ONE INVACARE WAY | ELYRIA | OH | 44036-2125 |
| K233707 | Invent Medical Corporation |
2788 Loker Ave. W. | Carlsbad | CA | 92010 |
| K990614 | KING SYSTEMS CORP. |
15011 HERRIMAN BLVD. | NOBLESVILLE | IN | 46060 |
| K242717 | Laboratorios Biogalenic, S.A. DE C.V. |
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango | San Salvador | 1639 | |
| K993268 | MALLINCKRODT DAR S.R.L. |
VIA G.BOVE, 2/4/6/8 | MIRANDOLA (MODENA) | 41037 | |
| K042184 | MALLINCKRODT DEVELOPPEMENT FRANCE |
10 ALLEE PELLETIER DOISY | VILLERS-LES-NANCY | 54601 | |
| K970478 | MARQUEST MEDICAL PRODUCTS, INC. |
11039 EAST LANSING CIR. | ENGLEWOOD | CO | 80112 |
| K962223 | MARQUEST MEDICAL PRODUCTS, INC. |
11039 EAST LANSING CIR. | ENGLEWOOD | CO | 80112 |
| K050990 | MEDICAL INDUSTRIES AMERICA, INC. |
2636 289TH PLACE | ADEL | IA | 50003-8021 |
| K052615 | MEDISIZE BV |
EDISONSTRAAT 1 | HILLEGOM | 2180 AB | |
| K070714 | MEDISIZE BV |
EDISONSTRAAT 1 | HILLEGOM | 2181 AB | |
| K122885 | MEDISIZE BV |
Prinsessegracht 20 | The Hague | 2514 AP | |
| K230559 | Medline Industries, Inc. |
1 Three Lake Drive | Northfiled | IL | 60093 |
| K241778 | Medline Industries, LP. |
Three Lakes Drive | Northfield | IL | 60093 |
| K250312 | Medline Industries, LP. |
Three Lakes Drive | Northfield | IL | 60093 |
| K240163 | Medline Industries, LP. |
Three Lakes Drive | Nortfield | IL | 60093 |
| K080149 | PACIFIC MEDICO CO., LTD. |
2-6-4HONGO, BUNKYO-KU, | TOKYO | 113-0033 | |
| K132857 | PACIFIC MEDICO CO., LTD. |
2-6-4 HONGO | BUNKYO-KU, TOKYO | 113-0033 | |
| K070107 | PARI INNOVATIVE MANUFACTURERS, INC. |
2943 OAKLAKE BLVD. | MIDLOTHIAN | VA | 23112 |
| K072982 | PARI INNOVATIVE MANUFACTURERS, INC. |
2943 OAKLAKE BLVD. | MIDLOTHIAN | VA | 23112 |
| K983783 | PEGASUS RESEARCH CORP. |
1714 SOUTH LYON ST. | SANTA ANA | CA | 92705 |
| K013856 | PEGASUS RESEARCH CORP. |
1714 SOUTH LYON ST. | SANTA ANA | CA | 92705 |
| K020700 | PEGASUS RESEARCH CORP. |
1714 SOUTH LYON ST. | SANTA ANA | CA | 92705 |
| K193411 | Perma Pure LLC |
1001 New Hampshire Ave | Lakewood | NJ | 08701 |
| K062091 | POROUS MEDIA CORP. |
1350 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K971260 | RESMED CORP. |
5744 PACIFIC CENTER BLVD., | SAN DIEGO | CA | 92121 |
| K080797 | RESMED LTD. |
14040 DANIELSON ST. | POWAY | CA | 92064-6857 |
| K983862 | RESPIRATORY SUPPORT PRODUCTS, INC. |
2552 MCGAW AVE. | IRVINE | CA | 92614 |
| K030090 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K945782 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K964653 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K012633 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K161719 | SALTER LABS |
2365 CAMINO VIDA ROBLE | Carlsbad | CA | 92011 |
| K113542 | SALTER LABS, ARVIN FACILITY |
100 Sycamore Rd | ARVIN | CA | 93203 |
| K963025 | SLEEPNET CORPORATION |
1050 PERIMETER RD., | MANCHESTER | NH | 03103 |
| K050314 | SMITHS MEDICAL ASD, INC. |
ONE MADISON ST. | WAMPSVILLE | NY | 13163 |
| K092256 | SMITHS MEDICAL ASD, INC. |
160 WEYMOUTH ST. | ROCKLAND | MA | 02370 |
| K071958 | SMITHS MEDICAL ASD, INC. |
160 WEYMOUTH ST. | ROCKLAND | MA | 02370 |
| K131388 | SOMNETICS INTERNATIONAL, INC. |
33 5TH AVE NW, STE 500 | NEW BRIGHTON | MN | 55112 |
| K003626 | SUNRISE MEDICAL HHG, INC. |
100 DEVILBISS DR. | SOMERSET | PA | 15501 |
| K020900 | SUNRISE MEDICAL HHG, INC. |
100 DEVILBISS DR. | SOMERSET | PA | 15501 |
| K031179 | TAGA MEDICAL TECHNOLOGIES, INC. |
34675 VOKES DR STE 105 | EASTLAKE | OH | 44095 |
| K010578 | TAGA MEDICAL TECHNOLOGIES, INC. |
7561 TYLER BLVD. | MENTOR | OH | 44060 |
| K040507 | TAGA MEDICAL TECHNOLOGIES, INC. |
34675 VOKES DR. | EASTLAKE | OH | 44095 |
| K063758 | TELEFLEX MEDICAL |
2345 WAUKEGAN ROAD | BANNOCKBURN | IL | 60015 |
| K061736 | TELEFLEX MEDICAL |
2345 WAUKEGAN ROAD | BANNOCKBURN | IL | 60015 |
| K141353 | TELEFLEX MEDICAL , INC. |
2917 WEEK DRIVE | RESEARCH TRIANGLE PARK | NC | 27709 |
| K162242 | TELEFLEX MEDICAL, INC |
2917 WECK DRIVE | RESEARCH TRIANGLE PARK | NC | 27709 |
| K140556 | TELEFLEX, INC. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K141940 | TELEFLEX, INC. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K131912 | TELEFLEX, INC. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K223863 | Telesair, Inc. |
204 Technology Drive, Suite F | Irvine | CA | 92618 |
| K180474 | TNI Medical AG |
Hofmannstr. 8 | Wuerzburg | 97084 | |
| K203357 | Vapotherm Inc. |
100 Domain Drive | Exeter | NH | 03833 |
| K103316 | VAPOTHERM, INC. |
198 Log Canoe Circle | Stevensville | MD | 21666 |
| K191010 | Vapotherm, Inc. |
100 Domain Drive | Exeter | NH | 03833 |
| K072845 | VAPOTHERM, INC. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 21666 |
| K111640 | VAPOTHERM, INC. |
198 Log Canoe Circle | Stevensville | MD | 21666 |
| K070056 | VAPOTHERM, INC. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 21666 |
| K013486 | VAPOTHERM, INC. |
6329 W.WATERVIEW CT. | MCCORDSVILLE | IN | 46055-9501 |
| K042245 | VAPOTHERM, INC. |
6329 W.WATERVIEW CT. | MCCORDSVILLE | IN | 46055-9501 |
| K000401 | VAPOTHERM, INC. |
163 CONDUIT ST. | ANNAPOLIS | MD | 21401 |
| K093617 | VENTLAB CORP. |
155 BOYCE DRIVE | MOCKSVILLE | NC | 27028 |
| K222351 | Vincent Healthcare Products Limited |
Flat/RM B2, 7/F., Hang Fung Industrial Building, Phase 2, | Hung Hom | ||
| K002454 | VITAL SIGNS, INC. |
11039 EAST LANSING CIRCLE | ENGLEWOOD | CO | |
| K231380 | Vyaire Medical, Inc. |
26125 N. Riverwoods Blvd. | Mettawa | IL | 60045 |
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