IE-ZEN (IN CLEAR SERIES HEARING AID)— 510(k) K110973
Substantially EquivalentWidex USA
FDA 510(k) clearance K110973 for IE-ZEN (IN CLEAR SERIES HEARING AID), Substantially Equivalent on 2011-05-05. Applicant: Widex USA.
Clearance details
- Applicant
- Widex USA
- Product code
- Code KLW
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lisle, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.