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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 the device name listed in this FDA 510(k) record. The listed applicant is Electrogenics Labs, Ltd.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) 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. The listed applicant is Electrogenics Labs, Ltd.. The 510(k) number is K250911.

When did MOSkin Radiation Measurement System receive FDA 510(k) clearance?

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

Who is the listed applicant for MOSkin Radiation Measurement System?

The FDA 510(k) record lists Electrogenics Labs, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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