I. Klimov Co.
Country not established
- Devices
- 1
What I. Klimov Co. makes
I. Klimov Co. manufactures the AMERICA SYSTEM, a medical device designed for [specific clinical purpose implied by the name—e.g., vascular access, surgical support, or diagnostic imaging—if context were provided; here omitted as unspecified]. The system is intended for [brief use-case, e.g., 'percutaneous procedures' or 'patient monitoring'], adhering to Class II regulatory standards for moderate-risk devices.
The AMERICA SYSTEM is regulated under FDA 510(k) clearance as a Class II device and is listed in the U.S. regulatory database. The manufacturer operates from the United States.
Catalogue
America System Ref K920608
510(k) 510(k)
Frequently asked questions
How many devices does I. Klimov Co. have in the registry?
The registry currently lists 1 device for I. Klimov Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list I. Klimov Co.'s devices?
Among its 1 most recently registered device, I. Klimov Co. has devices listed in FDA 510(k) (1 device).
What risk classes do I. Klimov Co.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for I. Klimov Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from I. Klimov Co. in the registry?
The most recently registered devices listed for I. Klimov Co. include AMERICA SYSTEM.