510(k) K182116
K182116 is an FDA 510(k) premarket notification submitted by Cochlear Americas for the device "BA310 Abutment, BIA310 Implant/Abutment". The FDA issued a decision of Substantially Equivalent on December 19, 2018. The device falls under product code MAH (Hearing Aid, Bone Conduction, Implanted), a Class II device regulated under 21 CFR 874.3302. Cochlear Americas has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2018
- Date Received
- August 6, 2018
- 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