K253431
- 510(k) number
- K253431
- Device name
- Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
- Applicant
- Shokz Health Global Limited HK
- Product code
- LXB — Hearing Aid, Bone Conduction
- Decision date
- 2026-08-19
- Date received
- 2025-10-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253431.pdf
Official FDA record: K253431
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.