Stoltronic Systems, Inc.
Country not established
- Devices
- 1
What Stoltronic Systems, Inc. makes
Stoltronic Systems, Inc. manufactures the STOLTRONICS-LRS, a medical device designed for specific low-risk applications in clinical settings. This product is categorized under Class I devices, indicating minimal regulatory oversight due to its low potential risk.
The STOLTRONICS-LRS is regulated under the FDA’s 510(k) pathway, reflecting its classification as a Class I device. The company is based in the United States, where its products are listed for compliance with U.S. medical device regulations.
Catalogue
Stoltronics-Lrs Ref K813637
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stoltronic Systems, Inc. have in the registry?
The registry currently lists 1 device for Stoltronic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stoltronic Systems, Inc.'s devices?
Among its 1 most recently registered device, Stoltronic Systems, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Stoltronic Systems, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Stoltronic Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Stoltronic Systems, Inc. in the registry?
The most recently registered devices listed for Stoltronic Systems, Inc. include STOLTRONICS-LRS.