FDA 510(k)

ControlRad Trace Model 8

K-Number: K183109 · 2019-05-13

Decision Date2019-05-13

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ControlRad Trace Model 8 is a medical device manufactured by Controlrad, Inc.. It received FDA 510(k) clearance on 2019-05-13 under approval number K183109. 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 Trace Model 8?

ControlRad Trace Model 8 is a medical device that received FDA 510(k) clearance on 2019-05-13. It is manufactured by Controlrad, Inc.. The 510(k) number is K183109.

When was ControlRad Trace Model 8 approved by the FDA?

ControlRad Trace Model 8 received FDA 510(k) clearance on 2019-05-13, under approval number K183109.

What company makes ControlRad Trace Model 8?

ControlRad Trace Model 8 is manufactured by Controlrad, Inc..

What is the FDA product code for ControlRad Trace Model 8?

The FDA product code for ControlRad Trace Model 8 is OWB.

Other Devices by Controlrad, Inc.

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