510(k) K090720
K090720 is an FDA 510(k) premarket notification submitted by Cochlear Bone Anchored Systems AB for the device "COCHLEAR BAHA BP100". The FDA issued a decision of Substantially Equivalent on June 17, 2009. The device falls under product code LXB (Hearing Aid, Bone Conduction), 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
- June 17, 2009
- Date Received
- March 18, 2009
- 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