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FDA 510(k)

ClearRead CT

K-Number: K161201 · 2016-09-09

ApplicantRiverain Technologies, LLC
Decision Date2016-09-09
Product CodeOEB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClearRead CT is a medical device manufactured by Riverain Technologies, LLC. It received FDA 510(k) clearance on 2016-09-09 under approval number K161201. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearRead CT?

ClearRead CT is a medical device that received FDA 510(k) clearance on 2016-09-09. It is manufactured by Riverain Technologies, LLC. The 510(k) number is K161201.

When was ClearRead CT approved by the FDA?

ClearRead CT received FDA 510(k) clearance on 2016-09-09, under approval number K161201.

What company makes ClearRead CT?

ClearRead CT is manufactured by Riverain Technologies, LLC.

What is the FDA product code for ClearRead CT?

The FDA product code for ClearRead CT is OEB.

Related Devices (Code: OEB)

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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.

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