FDA 510(k)

NICO Myriad NOVUS

K-Number: K191599 · 2019-09-13

Decision Date2019-09-13

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NICO Myriad NOVUS is a medical device manufactured by Nico Corporation. It received FDA 510(k) clearance on 2019-09-13 under approval number K191599. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICO Myriad NOVUS?

NICO Myriad NOVUS is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Nico Corporation. The 510(k) number is K191599.

When was NICO Myriad NOVUS approved by the FDA?

NICO Myriad NOVUS received FDA 510(k) clearance on 2019-09-13, under approval number K191599.

What company makes NICO Myriad NOVUS?

NICO Myriad NOVUS is manufactured by Nico Corporation.

What is the FDA product code for NICO Myriad NOVUS?

The FDA product code for NICO Myriad NOVUS is GEI.

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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.