510(k) K172460
K172460 is an FDA 510(k) premarket notification submitted by Med-El Elektromedizinische Geraete GmbH for the device "ADHEAR System". The FDA issued a decision of Substantially Equivalent on April 27, 2018. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302. Med-El Elektromedizinische Geraete GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2018
- Date Received
- August 14, 2017
- 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