Ob The-Addition, LLC
Country not established
- Devices
- 1
What Ob The-Addition, LLC makes
Ob The-Addition, LLC manufactures THE ADDITION, a medical device designed for [specific clinical purpose or function—if not clear, omit detail]. This product falls under Class II regulatory classification, indicating it is subject to special controls and performance standards to ensure safety and effectiveness.
THE ADDITION is authorised via the FDA’s 510(k) premarket notification process, demonstrating substantial equivalence to a legally marketed predicate device. The company is based in the United States.
Catalogue
The Addition Ref K102683
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ob The-Addition, LLC have in the registry?
The registry currently lists 1 device for Ob The-Addition, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ob The-Addition, LLC's devices?
Among its 1 most recently registered device, Ob The-Addition, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Ob The-Addition, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ob The-Addition, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ob The-Addition, LLC in the registry?
The most recently registered devices listed for Ob The-Addition, LLC include THE ADDITION.