PORTABLE BREAST COMPRESSION DEVICE — Pem Technologies (510(k) K003775)
PORTABLE BREAST COMPRESSION DEVICE — Pem Technologies (510(k) K003775) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: PORTABLE BREAST COMPRESSION DEVICE; Applicant: Pem Technologies; Clearance track: 510(k).
| Device name | PORTABLE BREAST COMPRESSION DEVICE |
|---|---|
| Applicant | Pem Technologies |
| Clearance track | 510(k) |
| Submission number | K003775 |
| Decision | Substantially Equivalent |
| Decision date | 2001-01-12 |
| Date received | 2000-12-06 |
| Product code | IYX |
| Device class | 1 |
| Medical specialty | Radiology |
| Applicant location | MD, US |
| Source | openFDA device |
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$1999/mo
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