OPTI-AMP — Intelligent Hearing Systems (510(k) K914876)
OPTI-AMP — Intelligent Hearing Systems (510(k) K914876) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: OPTI-AMP; Applicant: Intelligent Hearing Systems; Clearance track: 510(k).
| Device name | OPTI-AMP |
|---|---|
| Applicant | Intelligent Hearing Systems |
| Clearance track | 510(k) |
| Submission number | K914876 |
| Decision | Substantially Equivalent |
| Decision date | 1992-01-10 |
| Date received | 1991-10-29 |
| Product code | GWL |
| Device class | 2 |
| Medical specialty | Neurology |
| Applicant location | FL, US |
| Source | openFDA device |
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$1999/mo
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