3B Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What 3B Products, Inc. makes
3B Products, Inc. manufactures respiratory therapy devices, including continuous positive airway pressure (CPAP) machines such as the RESMART CPAP and RESMART AUTO-CPAP, as well as heated humidifiers like the RESMART HUMIDIFIER. These products are designed for use in managing sleep-related breathing disorders.
The company’s portfolio is regulated under Class II medical devices in the US and is listed in the FDA’s 510(k) clearance registry. The devices are based in the United States.
Catalogue
3B Flex-Lite Ref K103434
Regimes: 510(k) Registry: 510(k)3B Willow Ref K112271
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does 3B Products, Inc. have in the registry?
The registry currently lists 3 devices for 3B Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list 3B Products, Inc.'s devices?
Among its 3 most recently registered devices, 3B Products, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do 3B Products, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for 3B Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from 3B Products, Inc. in the registry?
The most recently registered devices listed for 3B Products, Inc. include 3B FLEX-LITE, 3B WILLOW and RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER.