K-number	K250963
Device name	PlanOne 1
Applicant	Cosylab Jsc, Control System Laboratory
Product code	MUJ
Device class	Class II
Decision date	Nov 20, 2025
Decision	Substantially Equivalent
Regulation	892.5050

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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PlanOne 1

Everything you need for a 510(k) submission. Nothing you don't.