P.H.D. - PERSONAL HEART DEVICE MODEL 5258 — Heart Alert, Inc. (510(k) K963904)
P.H.D. - PERSONAL HEART DEVICE MODEL 5258 — Heart Alert, Inc. (510(k) K963904) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: P.H.D. - PERSONAL HEART DEVICE MODEL 5258; Applicant: Heart Alert, Inc.; Clearance track: 510(k).
| Device name | P.H.D. - PERSONAL HEART DEVICE MODEL 5258 |
|---|---|
| Applicant | Heart Alert, Inc. |
| Clearance track | 510(k) |
| Submission number | K963904 |
| Decision | Substantially Equivalent |
| Decision date | 1997-05-15 |
| Date received | 1996-09-30 |
| Product code | DXH |
| Device class | 2 |
| Medical specialty | Cardiovascular |
| Applicant location | GA, US |
| Source | openFDA device |
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