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FDA Product Code

FDA Product Code QDD — Clearance Directory

Device Class
Class II
Assigned Panel
Ear, Nose, Throat
21 CFR Citation
874.3325

510(k) Clearances — 7 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K223911 Lumen 155-SF Intricon Corporation 2023-10-17 Traditional PDF ↗
K220403 Vibe SF Self-Fitting Hearing Aid Wsaud A/S 2022-08-12 Traditional PDF ↗
K220303 MDHearingAid app, MDHearingAid Smart hearing aids Mdhearingaid 2022-08-04 Traditional PDF ↗
K213424 Jabra Enhance Plus GN Hearing A/S 2022-01-19 Traditional PDF ↗
K212609 BHA100 Series Braun Clear Hearing Aid Kaz USA, Inc., A Helen of Troy Company 2022-01-05 Traditional PDF ↗
K211008 Bose SoundControl Hearing Aids Bose Corporation 2021-05-05 Special PDF ↗
DEN180026 Bose Hearing Aid Bose Corporation 2018-10-05 Direct —

Product code QDD · Class II · Ear, Nose, Throat. Data: openFDA.