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FDA 510(k)

Bose SoundControl Hearing Aids

K-Number: K211008 · 2021-05-05

ApplicantBose Corporation
Decision Date2021-05-05
Product CodeQDD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Bose SoundControl Hearing Aids is a medical device manufactured by Bose Corporation. It received FDA 510(k) clearance on 2021-05-05 under approval number K211008. The device is classified under product code QDD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bose SoundControl Hearing Aids?

Bose SoundControl Hearing Aids is a medical device that received FDA 510(k) clearance on 2021-05-05. It is manufactured by Bose Corporation. The 510(k) number is K211008.

When was Bose SoundControl Hearing Aids approved by the FDA?

Bose SoundControl Hearing Aids received FDA 510(k) clearance on 2021-05-05, under approval number K211008.

What company makes Bose SoundControl Hearing Aids?

Bose SoundControl Hearing Aids is manufactured by Bose Corporation.

What is the FDA product code for Bose SoundControl Hearing Aids?

The FDA product code for Bose SoundControl Hearing Aids is QDD.

Other Devices by Bose Corporation

DEN180026Bose Hearing Aid

Related Devices (Code: QDD)

DEN180026Bose Hearing AidBose Corporation K220403Vibe SF Self-Fitting Hearing AidWsaud A/S K220303MDHearingAid app, MDHearingAid Smart hearing aidsMdhearingaid K213424Jabra Enhance PlusGN Hearing A/S K212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company K223911Lumen 155-SFIntricon Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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