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FDA 510(k)

PlanOne 1

K-Number: K250963 · 2025-11-20

ApplicantCosylab Jsc, Control System Laboratory
Decision Date2025-11-20
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PlanOne 1 is a medical device manufactured by Cosylab Jsc, Control System Laboratory. It received FDA 510(k) clearance on 2025-11-20 under approval number K250963. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PlanOne 1?

PlanOne 1 is a medical device that received FDA 510(k) clearance on 2025-11-20. It is manufactured by Cosylab Jsc, Control System Laboratory. The 510(k) number is K250963.

When was PlanOne 1 approved by the FDA?

PlanOne 1 received FDA 510(k) clearance on 2025-11-20, under approval number K250963.

What company makes PlanOne 1?

PlanOne 1 is manufactured by Cosylab Jsc, Control System Laboratory.

What is the FDA product code for PlanOne 1?

The FDA product code for PlanOne 1 is MUJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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