Bruel & Kjaer Industri A/S
Country not established
- Devices
- 4
What Bruel & Kjaer Industri A/S makes
Bruel & Kjaer Industri A/S manufactures diagnostic ultrasound systems, including modified models like the Type 3535, and ultrasound scanners such as the Type 1842/1846/1849 series. Their portfolio also includes specialized medical devices like the biopsy fixation unit (Type UA 0997) and the rhino-larynx stroboscope (Type 4914).
These devices are classified under FDA regulations as Class I and Class II, with relevant submissions recorded in the 510(k) premarket notification database. The company operates within the United States.
Catalogue
Diagnostic Ultrasound System Type 3535, Modified Ref K914945
Regimes: 510(k) Registry: 510(k)Biopsy Fixation Unit-Type Ua 0997 Ref K875357
Regimes: 510(k) Registry: 510(k)Rhino-Larynx Stroboscope Type 4914 Ref K842090
Regimes: 510(k) Registry: 510(k)Amendment Ultrasound Scanner Type 1842/1846/1849 Ref K852502
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bruel & Kjaer Industri A/S have in the registry?
The registry currently lists 4 devices for Bruel & Kjaer Industri A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bruel & Kjaer Industri A/S's devices?
Among its 4 most recently registered devices, Bruel & Kjaer Industri A/S has devices listed in FDA 510(k) (4 devices).
What risk classes do Bruel & Kjaer Industri A/S's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Bruel & Kjaer Industri A/S's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bruel & Kjaer Industri A/S in the registry?
The most recently registered devices listed for Bruel & Kjaer Industri A/S include DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED, BIOPSY FIXATION UNIT-TYPE UA 0997, RHINO-LARYNX STROBOSCOPE TYPE 4914 and AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849.