OTOFLEX 100 TYE 1012— 510(k) K033645
Substantially EquivalentGn Otometrics A/S
FDA 510(k) clearance K033645 for OTOFLEX 100 TYE 1012, Substantially Equivalent on 2004-03-31. Applicant: Gn Otometrics A/S.
Clearance details
- Applicant
- Gn Otometrics A/S
- Product code
- Code ETY
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taastrup, DK
Data sourced from openFDA. This site is unofficial and independent of the FDA.