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FDA 510(k)

CNS Envision

K-Number: K192572 · 2019-12-17

ApplicantMoberg Research, Inc.
Decision Date2019-12-17
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CNS Envision is a medical device manufactured by Moberg Research, Inc.. It received FDA 510(k) clearance on 2019-12-17 under approval number K192572. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CNS Envision?

CNS Envision is a medical device that received FDA 510(k) clearance on 2019-12-17. It is manufactured by Moberg Research, Inc.. The 510(k) number is K192572.

When was CNS Envision approved by the FDA?

CNS Envision received FDA 510(k) clearance on 2019-12-17, under approval number K192572.

What company makes CNS Envision?

CNS Envision is manufactured by Moberg Research, Inc..

What is the FDA product code for CNS Envision?

The FDA product code for CNS Envision is OLT.

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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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