Firma Ingemarsson
DenmarkFDA applicant, unverified
- Devices
- 1
What Firma Ingemarsson makes
Firma Ingemarsson manufactures Noiselezz, a device designed to reduce or eliminate unwanted noise in audio environments, likely targeting applications such as hearing protection or sound masking.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. Noiselezz is listed in the FDA’s 510(k) registry. Firma Ingemarsson is based in the United States.
Catalogue
Noiselezz Ref K160531
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Firma Ingemarsson have in the registry?
The registry currently lists 1 device for Firma Ingemarsson. Devices recorded under merged duplicate company entries are counted once.
Which registries list Firma Ingemarsson's devices?
Among its 1 most recently registered device, Firma Ingemarsson has devices listed in FDA 510(k) (1 device).
What risk classes do Firma Ingemarsson's devices fall under?
Among its 1 most recently registered device, the classes recorded for Firma Ingemarsson's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Firma Ingemarsson in the registry?
The most recently registered devices listed for Firma Ingemarsson include Noiselezz.