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FDA 510(k)

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9

K-Number: K211782 · 2021-07-01

ApplicantControlrad, Inc.
Decision Date2021-07-01
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 is a medical device manufactured by Controlrad, Inc.. It received FDA 510(k) clearance on 2021-07-01 under approval number K211782. 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 Trace Model 8, ControlRad Trace Model 9?

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 is a medical device that received FDA 510(k) clearance on 2021-07-01. It is manufactured by Controlrad, Inc.. The 510(k) number is K211782.

When was ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 approved by the FDA?

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 received FDA 510(k) clearance on 2021-07-01, under approval number K211782.

What company makes ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9?

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 is manufactured by Controlrad, Inc..

What is the FDA product code for ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9?

The FDA product code for ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 is OWB.

Other Devices by Controlrad, Inc.

K183109ControlRad Trace Model 8 K202431ControlRad Select Model Z K200663ControlRad Trace Model 9 K200238ControlRad Sterile Cover K213455ControlRad Select Model Z

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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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