A/S Bruel & Kjaer
DK Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
What A/S Bruel & Kjaer makes
A/S Bruel & Kjaer manufactures in situ ear gain audio test systems, including the Type 2118/WH 1823 model, designed for measuring hearing aid performance within the ear canal.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does A/S Bruel & Kjaer manufacture?
A/S Bruel & Kjaer specializes in producing in situ ear gain audio test systems, such as the Type 2118/WH 1823 model. These devices are specifically designed to measure the real-world performance of hearing aids inside the ear canal, ensuring accurate fitting and functionality for patients.
Where is A/S Bruel & Kjaer based?
The company has its headquarters and operations based in the United States. This location allows it to align with regulatory requirements and market demands specific to the US healthcare system.
How are A/S Bruel & Kjaer’s devices classified under FDA regulations?
A/S Bruel & Kjaer’s in situ ear gain audio test systems fall under Class II classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance testing and labeling requirements.
Which regulatory registries or pathways list A/S Bruel & Kjaer’s devices?
A/S Bruel & Kjaer’s devices are listed via the FDA 510(k) pathway, a premarket submission process used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This pathway ensures compliance with FDA requirements before the devices enter the market.
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