FDA 510(k)

SunCHECK

K-Number: K170307 · 2017-10-25

Decision Date2017-10-25

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SunCHECK is a medical device manufactured by Sun Nuclear Corporation. It received FDA 510(k) clearance on 2017-10-25 under approval number K170307. 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 SunCHECK?

SunCHECK is a medical device that received FDA 510(k) clearance on 2017-10-25. It is manufactured by Sun Nuclear Corporation. The 510(k) number is K170307.

When was SunCHECK approved by the FDA?

SunCHECK received FDA 510(k) clearance on 2017-10-25, under approval number K170307.

What company makes SunCHECK?

SunCHECK is manufactured by Sun Nuclear Corporation.

What is the FDA product code for SunCHECK?

The FDA product code for SunCHECK is IYE.

Other Devices by Sun Nuclear Corporation

K161946DoseCHECK K160057ArcCHECK-MR

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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.