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FDA 510(k)

SciMoCa

K-Number: K180595 · 2018-04-04

ApplicantRadialogica, LLC
Decision Date2018-04-04
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SciMoCa is a medical device manufactured by Radialogica, LLC. It received FDA 510(k) clearance on 2018-04-04 under approval number K180595. 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 SciMoCa?

SciMoCa is a medical device that received FDA 510(k) clearance on 2018-04-04. It is manufactured by Radialogica, LLC. The 510(k) number is K180595.

When was SciMoCa approved by the FDA?

SciMoCa received FDA 510(k) clearance on 2018-04-04, under approval number K180595.

What company makes SciMoCa?

SciMoCa is manufactured by Radialogica, LLC.

What is the FDA product code for SciMoCa?

The FDA product code for SciMoCa is IYE.

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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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