ELITE — Biotone International, Inc. (510(k) K812538)
ELITE — Biotone International, Inc. (510(k) K812538) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ELITE; Applicant: Biotone International, Inc.; Clearance track: 510(k).
| Device name | ELITE |
|---|---|
| Applicant | Biotone International, Inc. |
| Clearance track | 510(k) |
| Submission number | K812538 |
| Decision | Substantially Equivalent |
| Decision date | 1981-12-01 |
| Date received | 1981-09-03 |
| Product code | IPF |
| Device class | 2 |
| Medical specialty | Physical Medicine |
| Applicant location | MI, US |
| Source | openFDA device |
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$1999/mo
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