FDA 510(k)

ControlRad Select Model Z

K-Number: K213455 · 2021-11-24

Decision Date2021-11-24

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ControlRad Select Model Z is a medical device manufactured by Controlrad, Inc.. It received FDA 510(k) clearance on 2021-11-24 under approval number K213455. 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 ControlRad Select Model Z?

ControlRad Select Model Z is a medical device that received FDA 510(k) clearance on 2021-11-24. It is manufactured by Controlrad, Inc.. The 510(k) number is K213455.

When was ControlRad Select Model Z approved by the FDA?

ControlRad Select Model Z received FDA 510(k) clearance on 2021-11-24, under approval number K213455.

What company makes ControlRad Select Model Z?

ControlRad Select Model Z is manufactured by Controlrad, Inc..

What is the FDA product code for ControlRad Select Model Z?

The FDA product code for ControlRad Select Model Z is OWB.

Other Devices by Controlrad, Inc.

K183109ControlRad Trace Model 8 K202431ControlRad Select Model Z K200663ControlRad Trace Model 9 K200238ControlRad Sterile Cover 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.