WIDEXLINK IN CLEAR SERIES HEARING AIDS
FDA 510(k) clearance DEN100025 · decided 2011-03-31
Clearance details
- K-number
- DEN100025
- Device name
- WIDEXLINK IN CLEAR SERIES HEARING AIDS
- Applicant
- Office Research IN Clinical Amplifiction
- Decision
- Unknown
- Date received
- 2010-10-13
- Decision date
- 2011-03-31
- Days to decision
- 169 days
- Clearance type
- Post-NSE
- Product code
- OSM
- Device class
- 2
- Regulation number
- 874.3305
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Lisle, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.