OTOFLEX 100 TYE 1012 — Gn Otometrics A/S (510(k) K033645)
OTOFLEX 100 TYE 1012 — Gn Otometrics A/S (510(k) K033645) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: OTOFLEX 100 TYE 1012; Applicant: Gn Otometrics A/S; Clearance track: 510(k).
| Device name | OTOFLEX 100 TYE 1012 |
|---|---|
| Applicant | Gn Otometrics A/S |
| Clearance track | 510(k) |
| Submission number | K033645 |
| Decision | Substantially Equivalent |
| Decision date | 2004-03-31 |
| Date received | 2003-11-20 |
| Product code | ETY |
| Device class | 2 |
| Medical specialty | Ear, Nose, Throat |
| Applicant location | DK |
| Source | openFDA device |
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$1999/mo
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