FDA 510(k)

ControlRad Sterile Cover

K-Number: K200238 · 2020-04-26

Decision Date2020-04-26

Product CodeKKX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ControlRad Sterile Cover is a medical device manufactured by Controlrad, Inc.. It received FDA 510(k) clearance on 2020-04-26 under approval number K200238. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ControlRad Sterile Cover?

ControlRad Sterile Cover is a medical device that received FDA 510(k) clearance on 2020-04-26. It is manufactured by Controlrad, Inc.. The 510(k) number is K200238.

When was ControlRad Sterile Cover approved by the FDA?

ControlRad Sterile Cover received FDA 510(k) clearance on 2020-04-26, under approval number K200238.

What company makes ControlRad Sterile Cover?

ControlRad Sterile Cover is manufactured by Controlrad, Inc..

What is the FDA product code for ControlRad Sterile Cover?

The FDA product code for ControlRad Sterile Cover is KKX.

Other Devices by Controlrad, Inc.

K183109ControlRad Trace Model 8 K202431ControlRad Select Model Z K200663ControlRad Trace Model 9 K213455ControlRad Select Model Z K211782ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9

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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.