FDA 510(k) Applications for Medical Device:
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K993833 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K000697 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K151303 | CAREFUSION |
75 NORTH FAIRWAY DRIVE | VERNON HILLS | IL | 60047 |
| K153234 | CAREFUSION INC |
75 N FAIRWAY DRIVE | VERNON HILLS | IL | 600601 |
| K151959 | CAREFUSION INC |
75 N FAIRWAY DRIVE | VERNON HILLS | IL | 60061 |
| K222822 | Draegerwerk AG & Co. KGaA |
Moislinger Allee 53-55 | Luebeck | 23542 | |
| K241268 | Exceleron Medical |
5000 Township Parkway | St. Paul | MN | 55110 |
| K103767 | FISHER & PAYKEL HEALTHCARE LTD. |
15 MAURICE PAYKEL PLACE | AUCKLAND | 1071 | |
| K122432 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | EAST TAMAKI | 2013 | |
| K034026 | FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE | AUCKLAND | 1701 | |
| K160540 | FLEXICARE MEDICAL LIMITED |
CYNON VALLEY BUSINESS PARK | MOUNTAIN ASH | CF45 4ER | |
| K150900 | FLEXICARE MEDICAL LTD. |
CYNON VALLEY BUSINESS PARK | MID GLAMORGAN | CF45 4ER | |
| K243244 | GuangDong EDA Technology Co., Ltd |
No. 6, Ma'an 2nd Road, Chashan Town | Guangdong Province | 523393 | |
| K092129 | INTERSURGICAL, INC. |
417 ELECTRONICS PKWY. | LIVERPOOL | NY | 13088 |
| K962220 | MARQUEST MEDICAL PRODUCTS, INC. |
11039 EAST LANSING CIR. | ENGLEWOOD | CO | 80112 |
| K234032 | Medline Industries, LP |
Three Lakes Drive | Northfield | IL | 60093 |
| K952267 | NOVA-VENTRX |
1974 RAYMOND DR. | NORTHBROOK | IL | 60062 |
| K100104 | PLASTIFLEX GROUP NV |
220 RIVER ROAD | CLAREMONT | NH | 03743 |
| K151461 | PLASTIFLEX GROUP NV |
BEVERLOOSESTEENWEG 99 | PAAL-BERINGEN | 3583 | |
| K110398 | RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY | MONROEVILLE | PA | 15146 |
| K140424 | RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY | MONROEVILLE | PA | 15146 |
| K201418 | Sunset Healthcare Solutions, Inc. |
180 N. Michigan Ave, Suite 2000 | Chicago | IL | 60601 |
| K173280 | Teleflex Medical, Inc |
3015 Carrington Mill Blvd-6N | Morrisville | NC | 27560 |
| K170378 | Vyaire Medical |
75 North Fairway Drive | Vernon Hills | IL | 60061 |
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