Auris Health, Inc., A Johnson and Johnson Family Company
United StatesFDA applicant, unverified
- Devices
- 2
What Auris Health, Inc., A Johnson and Johnson Family Company makes
Auris Health manufactures the Monarch Bronchoscope, a flexible bronchoscopic device designed for airway visualization and biopsy procedures in the respiratory tract.
The Monarch Bronchoscope is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Monarch Bronchoscope Ref K203614
Regimes: 510(k) Registry: 510(k)Monarch Bronchoscope Ref K231473
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Auris Health, Inc., A Johnson and Johnson Family Company have in the registry?
The registry currently lists 2 devices for Auris Health, Inc., A Johnson and Johnson Family Company. Devices recorded under merged duplicate company entries are counted once.
Which registries list Auris Health, Inc., A Johnson and Johnson Family Company's devices?
Among its 2 most recently registered devices, Auris Health, Inc., A Johnson and Johnson Family Company has devices listed in FDA 510(k) (2 devices).
What risk classes do Auris Health, Inc., A Johnson and Johnson Family Company's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Auris Health, Inc., A Johnson and Johnson Family Company's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Auris Health, Inc., A Johnson and Johnson Family Company in the registry?
The most recently registered devices listed for Auris Health, Inc., A Johnson and Johnson Family Company include Monarch Bronchoscope.