Cosylab Jsc, Control System Laboratory
SI Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
PlanOne 1 Ref K250963
What Cosylab Jsc, Control System Laboratory makes
Cosylab JSC manufactures the PlanOne 1, a medical device designed for precise control systems in clinical settings, likely for applications such as patient monitoring or procedural support.
The PlanOne 1 is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) registry. The company is based in the United States.
Frequently asked questions
What types of medical devices does Cosylab JSC manufacture?
Cosylab JSC specializes in medical devices focused on precise control systems for clinical environments. Their primary example, the PlanOne 1, appears to be designed for applications like patient monitoring or procedural support, emphasizing accuracy and reliability in healthcare settings.
Where is Cosylab JSC based?
Cosylab JSC is headquartered in the United States. Their location supports their role in developing and distributing medical devices tailored to regulatory standards and clinical needs within the US market.
Which regulatory registries list Cosylab JSC’s devices?
The PlanOne 1, one of Cosylab JSC’s devices, is listed in the FDA’s 510(k) registry. This classification indicates it has undergone the required premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device under FDA regulations.
How are Cosylab JSC’s devices classified under FDA regulations?
The PlanOne 1 is classified as a Class II device by the FDA. This classification typically applies to devices that pose moderate risk and require special controls in addition to general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
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