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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 the device name listed in this FDA 510(k) record. The listed applicant is Moberg Research, Inc.. It received FDA 510(k) clearance on 2019-12-17 under 510(k) 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. The listed applicant is Moberg Research, Inc.. The 510(k) number is K192572.

When did CNS Envision receive FDA 510(k) clearance?

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

Who is the listed applicant for CNS Envision?

The FDA 510(k) record lists Moberg Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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