NeuroNav System, NeuroSmart System
K-Number: K172042 · 2018-02-27
ApplicantAlpha Omega Engineering , Ltd.
Decision Date2018-02-27
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
NeuroNav System, NeuroSmart System is a medical device manufactured by Alpha Omega Engineering , Ltd.. It received FDA 510(k) clearance on 2018-02-27 under approval number K172042. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NeuroNav System, NeuroSmart System?
NeuroNav System, NeuroSmart System is a medical device that received FDA 510(k) clearance on 2018-02-27. It is manufactured by Alpha Omega Engineering , Ltd.. The 510(k) number is K172042.
When was NeuroNav System, NeuroSmart System approved by the FDA?
NeuroNav System, NeuroSmart System received FDA 510(k) clearance on 2018-02-27, under approval number K172042.
What company makes NeuroNav System, NeuroSmart System?
NeuroNav System, NeuroSmart System is manufactured by Alpha Omega Engineering , Ltd..
What is the FDA product code for NeuroNav System, NeuroSmart System?
The FDA product code for NeuroNav System, NeuroSmart System is GZL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.