510(k) K081606
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2008
- Date Received
- June 6, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Bone Conduction
- Device Class
- Class II
- Regulation Number
- 874.3302
- Review Panel
- EN
- Submission Type