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FDA 510(k)

Shield System

K-Number: K212159 · 2022-03-30

ApplicantRadiaction , Ltd.
Decision Date2022-03-30
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Shield System is a medical device manufactured by Radiaction , Ltd.. It received FDA 510(k) clearance on 2022-03-30 under approval number K212159. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shield System?

Shield System is a medical device that received FDA 510(k) clearance on 2022-03-30. It is manufactured by Radiaction , Ltd.. The 510(k) number is K212159.

When was Shield System approved by the FDA?

Shield System received FDA 510(k) clearance on 2022-03-30, under approval number K212159.

What company makes Shield System?

Shield System is manufactured by Radiaction , Ltd..

What is the FDA product code for Shield System?

The FDA product code for Shield System is OWB.

Other Devices by Radiaction , Ltd.

K222625Shield System

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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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