FDA 510(k) Applications for Medical Device:
Apparatus, Nitric Oxide Delivery
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K212409 | Airgas Therapeutics |
12800 West Little York Road | Houston | TX | 77041 |
| K000186 | DATEX-OHMEDA |
PO BOX 7550 | MADISON | WI | 53707 |
| K120216 | GENO LLC |
2941 OXBOW CIRCLE | COCOA | FL | 32926 |
| K061901 | INO THERAPEUTICS |
7601-B MURPHY DRIVE | MIDDLETON | WI | 53562 |
| K093922 | INO THERAPEUTICS |
2902 DAIRY DRIVE | MADISON | WI | 53718 |
| K121021 | INO THERAPEUTICS |
2902 DAIRY DRIVE | MADISON | WI | 53718 |
| K080484 | INO THERAPEUTICS |
6 ROUTE 173 | CLINTON | NJ | 08809 |
| K110344 | INO THERAPEUTICS |
2902 DAIRY DRIVE | MADISON | WI | 53718 |
| K130605 | INO THERAPEUTICS |
2902 DAIRY DRIVE | MADISON | WI | 53718 |
| K071516 | INO THERAPEUTICS LLC |
6 ROUTE 173 | CLINTON | NJ | 08809 |
| K081691 | INO THERAPEUTICS LLC |
2820 WALTON COMMONS WEST | MADISON | WI | 53718 |
| K092545 | INO THERAPEUTICS LLC |
2902 DAIRY DR. | MADISON | WI | 53718 |
| K070867 | INO THERAPEUTICS LLC |
6 ROUTE 173 | CLINTON | NJ | 08809 |
| K113272 | INO THERAPEUTICS LLC/DBA IKARIA |
1060 Allendale Dr | Port Allen | LA | 70767 |
| K110635 | INO THERAPEUTICS LLC/DBA IKARIA |
1060 Allendale Dr | Port Allen | LA | 70767 |
| K131686 | INO THERAPEUTICS/IKARIA |
2902 DAIRY DRIVE | MADISON | WI | 53718 |
| K143213 | INO Therapeutics/Ikaria |
6603 Femrite Drive | Madison | WI | 53718 |
| K193481 | International Biomedical |
8206 Cross Park Drive | Austin | TX | 78754 |
| K093260 | INTERNATIONAL BIOMEDICAL, LTD. |
8508 CROSS PARK DR. | AUSTIN | TX | 78754 |
| K220898 | Linde Gas & Equipment Inc. |
175 E Park Drive | Tonawanda | NY | 14150 |
| K231823 | Linde Gas & Equipment Inc. |
208 W Main St. | Livingston | TN | 38570 |
| K211153 | Mallinckrodt Manufacturing LLC |
6603 Femrite Drive | Madison | WI | 53718 |
| K200389 | Mallinckrodt Manufacturing LLC |
6603 Femrite Drive | Madison | WI | 53718 |
| DEN000001 | OHMEDA MEDICAL |
P.O. BOX 7550 | MADISON | WI | 53707-7550 |
| K171696 | Praxair Distribution, Inc |
10 Riverview Drive | Danbury | CT | 06810 |
| K201339 | Praxair, Inc. |
10 Riverview Drive | Danbury | CT | 06810 |
| K000653 | PULMONOX MEDICAL CORP. |
5243-53 AVE. | TOFIELD, ALBERTA | T0B 4J0 | |
| K033779 | PULMONOX MEDICAL, INC. |
10835-120 ST. | EDMONTON, AB | T5H 3P9 |
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