FDA 510(k) Applications for Medical Device:
System, Hemodialysis, Access Recirculation Monitoring
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K954003 | COBE RENAL CARE, INC. |
1201 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K180410 | Dosis, Inc. |
4388 El Camino Real, Unit 330 | Los Altos | CA | 94022 |
| K941460 | FRESENIUS USA, INC. |
2637 SHADELANDS DR. | WALNUT CREEK | CA | 94598 |
| K953551 | H&H CONTROL SYSTEMS |
1200 HESTER LN. | JACKSON | MS | 39209 |
| K984194 | HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1085 |
| K993587 | HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1085 |
| K953875 | IN-LINE DIAGNOSTICS CORP. |
4646 S. 1500 W.,SUITE 160 | RIVERDALE | UT | 84405 |
| K972470 | IN-LINE DIAGNOSTICS CORP. |
55 NORTHERN BLVD. | GREAT NECK | NY | 11021 |
| K992227 | IN-LINE DIAGNOSTICS CORP. |
117 W. 200 S. | FARMINGTON | UT | 84025 |
| K001763 | IN-LINE DIAGNOSTICS CORP. |
695 NORTH, 900 WEST | KAYSVILLE | UT | 84037 |
| K982412 | IN-LINE DIAGNOSTICS CORP. |
117 WEST 200 SOUTH | FARMINGTON | UT | 84025 |
| K130579 | PHYSICIANS SOFTWARE SYSTEMS, LLC |
3333 WARRENVILLE ROAD | LISLE | IL | 60532 |
| K960817 | TRANSONIC SYSTEMS, INC. |
34 DUTCH MILL RD. | ITHACA | NY | 14850 |
| K021571 | TRANSONIC SYSTEMS, INC. |
34 DUTCH MILL RD. | ITHACA | NY | 14850 |
| K980906 | TRANSONIC SYSTEMS, INC. |
34 DUTCH MILL RD. | ITHACA | NY | 14850 |
| K022963 | TRANSONIC SYSTEMS, INC. |
34 DUTCH MILL RD. | ITHACA | NY | 14850 |
| K042566 | VASC-ALERT, INC. |
1807 WEST SUNNYSIDE AVE. | CHICAGO | IL | 60640 |
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