Lgch, Inc.
Country not established
- Devices
- 1
What Lgch, Inc. makes
Lgch, Inc. manufactures the Companion, a medical device designed for [specific clinical purpose or function—if unspecified, omit detail]. This product is intended for [brief use case, e.g., diagnostic imaging, patient monitoring, or therapeutic intervention—if unspecified, omit detail].
The Companion is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The device is registered in the U.S. market, adhering to FDA compliance requirements.
Catalogue
Companion Ref DEN140033
Regimes: De Novo Registry: De Novo
Frequently asked questions
How many devices does Lgch, Inc. have in the registry?
The registry currently lists 1 device for Lgch, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lgch, Inc.'s devices?
Among its 1 most recently registered device, Lgch, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Lgch, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Lgch, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lgch, Inc. in the registry?
The most recently registered devices listed for Lgch, Inc. include Companion.