Home / 510(k) Clearances / K243041

510(k) K243041

contact forte Alpha by Bhm-Tech Produktionsgesellschaft Mbh — Product Code LXB

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

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