Bose SoundControl Hearing Aids— 510(k) K211008

Name: FDA 510(k) clearance K211008
Creator: U.S. Food and Drug Administration
Published: 2021-05-05

Substantially Equivalent

Bose Corporation

FDA 510(k) clearance K211008 for Bose SoundControl Hearing Aids, Substantially Equivalent on 2021-05-05. Applicant: Bose Corporation. Device class: 2.

Clearance details

Applicant: Bose Corporation
Product code: Code QDD
Device class: Class 2
Regulation: 21 CFR 874.3325
Advisory panel: Ear, Nose, Throat
Date received: 2021-04-05
Decision date: 2021-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Framingham, MA, 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.