Aearo Company
Country not established
- Devices
- 4
What Aearo Company makes
The company manufactures surgical N95 respirators, including models N9508C, N9511C, N9504C, N9504CS, N9514C, and Pleats Plus N95 respirators (models 1054 and 1054S). These devices are designed for healthcare professionals to filter airborne particles, reducing inhalation risks during surgical procedures.
The portfolio consists of Class II medical devices, each authorised via the FDA’s 510(k) pathway. These respirators are listed under the FDA’s regulatory framework and comply with U.S. standards for surgical protection. The company operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aearo Company have in the registry?
The registry currently lists 4 devices for Aearo Company. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aearo Company's devices?
Among its 4 most recently registered devices, Aearo Company has devices listed in FDA 510(k) (4 devices).
What risk classes do Aearo Company's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Aearo Company's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aearo Company in the registry?
The most recently registered devices listed for Aearo Company include AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C, PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S, N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C and PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S.