510(k) K243041
K243041 is an FDA 510(k) premarket notification submitted by Bhm-Tech Produktionsgesellschaft Mbh for the device "contact forte Alpha". The FDA issued a decision of Substantially Equivalent on April 25, 2025. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2025
- Date Received
- September 27, 2024
- 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