CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA — Paieon, Inc. (510(k) K073328)
CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA — Paieon, Inc. (510(k) K073328) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA; Applicant: Paieon, Inc.; Clearance track: 510(k).
| Device name | CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA |
|---|---|
| Applicant | Paieon, Inc. |
| Clearance track | 510(k) |
| Submission number | K073328 |
| Decision | Substantially Equivalent |
| Decision date | 2008-09-09 |
| Date received | 2007-11-27 |
| Product code | IZI |
| Device class | 2 |
| Medical specialty | Radiology |
| Applicant location | IL |
| Source | openFDA device |
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$1999/mo
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