FDA 510(k) Application Details - K220303

Device Classification Name	More FDA Info for this Device
510(K) Number	K220303
Device Name	MDHearingAid app, MDHearingAid Smart hearing aids
Applicant	MDHearingAid 150 N Michigan Avenue Suite 400 Chicago, IL 60601 US Other 510(k) Applications for this Company
Contact	Doug Breaker Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2022
Decision Date	08/04/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review