Device Listing 1608902903

Listing Summary#

Listing key
1608902903
Premarket submission
K253431
Device
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
Product code
LXB
Decision date
2026-08-19