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FDA 510(k)

MOSkin Radiation Measurement System

K-Number: K250911 · 2025-10-17

ApplicantElectrogenics Labs, Ltd.
Decision Date2025-10-17
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOSkin Radiation Measurement System is a medical device manufactured by Electrogenics Labs, Ltd.. It received FDA 510(k) clearance on 2025-10-17 under approval number K250911. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOSkin Radiation Measurement System?

MOSkin Radiation Measurement System is a medical device that received FDA 510(k) clearance on 2025-10-17. It is manufactured by Electrogenics Labs, Ltd.. The 510(k) number is K250911.

When was MOSkin Radiation Measurement System approved by the FDA?

MOSkin Radiation Measurement System received FDA 510(k) clearance on 2025-10-17, under approval number K250911.

What company makes MOSkin Radiation Measurement System?

MOSkin Radiation Measurement System is manufactured by Electrogenics Labs, Ltd..

What is the FDA product code for MOSkin Radiation Measurement System?

The FDA product code for MOSkin Radiation Measurement System is IYE.

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Official Source

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

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