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FDA 510(k)

BHA100 Series Braun Clear Hearing Aid

K-Number: K212609 · 2022-01-05

ApplicantKaz USA, Inc., A Helen of Troy Company
Decision Date2022-01-05
Product CodeQDD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BHA100 Series Braun Clear Hearing Aid is a medical device manufactured by Kaz USA, Inc., A Helen of Troy Company. It received FDA 510(k) clearance on 2022-01-05 under approval number K212609. 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 BHA100 Series Braun Clear Hearing Aid?

BHA100 Series Braun Clear Hearing Aid is a medical device that received FDA 510(k) clearance on 2022-01-05. It is manufactured by Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K212609.

When was BHA100 Series Braun Clear Hearing Aid approved by the FDA?

BHA100 Series Braun Clear Hearing Aid received FDA 510(k) clearance on 2022-01-05, under approval number K212609.

What company makes BHA100 Series Braun Clear Hearing Aid?

BHA100 Series Braun Clear Hearing Aid is manufactured by Kaz USA, Inc., A Helen of Troy Company.

What is the FDA product code for BHA100 Series Braun Clear Hearing Aid?

The FDA product code for BHA100 Series Braun Clear Hearing Aid is QDD.

Related Clinical Trials

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Other Devices by Kaz USA, Inc., A Helen of Troy Company

K161933The Braun ThermoScan® 3 High Speed Compact Ear Thermometer K152975VDT985US Vicks SmartTemp Thermometer K163516Braun No Touch + Forehead NTF3000 Thermometer K180131Vicks RapidRead Digital Thermometer K181242Braun BNT400 No Touch + Forehead Thermometer K181015Braun BFH175 Infrared Forehead Thermometer

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Related Devices (Code: QDD)

DEN180026Bose Hearing AidBose Corporation K211008Bose SoundControl Hearing AidsBose Corporation K220403Vibe SF Self-Fitting Hearing AidWsaud A/S K220303MDHearingAid app, MDHearingAid Smart hearing aidsMdhearingaid K213424Jabra Enhance PlusGN Hearing A/S 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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