510(k) K132189
K132189 is an FDA 510(k) premarket notification submitted by Sophono, Inc. for the device "OTOMAG BONE CONDUCATION HEARING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 22, 2013. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302. Sophono, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2013
- Date Received
- July 15, 2013
- 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