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FDA 510(k)

ClearCheck

K-Number: K162468 · 2016-12-01

ApplicantRadformation
Decision Date2016-12-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClearCheck is a medical device manufactured by Radformation. It received FDA 510(k) clearance on 2016-12-01 under approval number K162468. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearCheck?

ClearCheck is a medical device that received FDA 510(k) clearance on 2016-12-01. It is manufactured by Radformation. The 510(k) number is K162468.

When was ClearCheck approved by the FDA?

ClearCheck received FDA 510(k) clearance on 2016-12-01, under approval number K162468.

What company makes ClearCheck?

ClearCheck is manufactured by Radformation.

What is the FDA product code for ClearCheck?

The FDA product code for ClearCheck is IYE.

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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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