510(k) K080363
K080363 is an FDA 510(k) premarket notification submitted by Cochlear Bone Anchored Systems AB for the device "BAHA CORDELLE II". The FDA issued a decision of Substantially Equivalent on April 10, 2008. The device falls under product code MAH (Hearing Aid, Bone Conduction, Implanted), a Class II device regulated under 21 CFR 874.3302. Cochlear Bone Anchored Systems AB has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2008
- Date Received
- February 11, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Bone Conduction, Implanted
- Device Class
- Class II
- Regulation Number
- 874.3302
- Review Panel
- EN
- Submission Type