MDHearingAid app, MDHearingAid Smart hearing aids— 510(k) K220303

Name: FDA 510(k) clearance K220303
Creator: U.S. Food and Drug Administration
Published: 2022-08-04

Substantially Equivalent

Mdhearingaid

FDA 510(k) clearance K220303 for MDHearingAid app, MDHearingAid Smart hearing aids, Substantially Equivalent on 2022-08-04. Applicant: Mdhearingaid. Device class: 2.

Clearance details

Applicant: Mdhearingaid
Product code: Code QDD
Device class: Class 2
Regulation: 21 CFR 874.3325
Advisory panel: Ear, Nose, Throat
Date received: 2022-02-02
Decision date: 2022-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.