FDA 510(k) Applications for Medical Device:
Device, Positive Pressure Breathing, Intermittent
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K213564 | ABMRC LLC |
860 Blue Gentian Road Suite 200 | Eagan | MN | 55121 |
| K191912 | ABMRC LLC |
239, Fair Child Street, Daniel Island | Charleston | SC | 29492 |
| K051964 | COMEDICA , INC. |
2300 MCDERMOTT ROAD | PLANO | TX | 75025 |
| K140605 | DIMA ITALIA SRL |
via Coriolano Vighi, 29 | Bologna | 40133 | |
| K072292 | DIMA ITALIA SRL |
4655 KIRKWOOD CT. | BOULDER | CO | 80301 |
| K140598 | DIMA ITALIA SRL |
via Coriolano Vighi, 29 | Bologna | 40133 | |
| K192143 | Hill-Rom Services Pte Ltd |
1 Yishun Ave 7 | Singapore | ||
| K200988 | Hill-Rom Services Pte Ltd |
1 Yishun Ave 7 | Singapore | 768923 | |
| K124032 | HILL-ROM SERVICES PTE LTD |
1 YISHUN AVE 7 | SINGAPORE | 768923 | |
| K151689 | Hill-Rom Services Pte Ltd |
1 Yishun Ave 7 | Singapore | 768923 | |
| K002598 | J. H. EMERSON CO. |
22 COTTAGE PARK AVE. | CAMBRIDGE | MA | 02140-1691 |
| K120277 | LUNG ASSIST, INC. |
4655 KIRKWOOD COURT | BOULDER | CO | 80301 |
| K132988 | LUNG ASSIST, INC. |
4655 KIRKWOOD COURT | BOULDER | CO | 80301 |
| K121955 | RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY | MONROEVILLE | PA | 15146 |
| K113549 | SEOIL PACIFIC CORP. |
RM # 515-516, ACE HIGH-END | SEOUL | 573-901 | |
| K003684 | VORTRAN MEDICAL TECHNOLOGY 1, INC. |
3941 J ST., SUITE 354 | SACRAMENTO | CA | 95819 |
| K981726 | VORTRAN MEDICAL TECHNOLOGY 1, INC. |
3941 J ST., SUITE 354 | SACRAMENTO | CA | 95819 |
| K982016 | VORTRAN MEDICAL TECHNOLOGY 1, INC. |
3941 J ST., SUITE 354 | SACRAMENTO | CA | 95819 |
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