510(k) K212136
K212136 is an FDA 510(k) premarket notification submitted by Cochlear Americas for the device "Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App". The FDA issued a decision of Substantially Equivalent on September 29, 2021. The device falls under product code LXB (Hearing Aid, Bone Conduction), 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
- September 29, 2021
- Date Received
- July 8, 2021
- 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