FDA 510(k)

Liver Incytes, Model 1005

K-Number: K201597 · 2020-07-31

Decision Date2020-07-31

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Liver Incytes, Model 1005 is a medical device manufactured by Sonic Incytes. It received FDA 510(k) clearance on 2020-07-31 under approval number K201597. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Liver Incytes, Model 1005?

Liver Incytes, Model 1005 is a medical device that received FDA 510(k) clearance on 2020-07-31. It is manufactured by Sonic Incytes. The 510(k) number is K201597.

When was Liver Incytes, Model 1005 approved by the FDA?

Liver Incytes, Model 1005 received FDA 510(k) clearance on 2020-07-31, under approval number K201597.

What company makes Liver Incytes, Model 1005?

Liver Incytes, Model 1005 is manufactured by Sonic Incytes.

What is the FDA product code for Liver Incytes, Model 1005?

The FDA product code for Liver Incytes, Model 1005 is IYO.

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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.