NEURONAUTE
K-Number: K170138 · 2017-12-26
ApplicantBioserenity
Decision Date2017-12-26
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
NEURONAUTE is a medical device manufactured by Bioserenity. It received FDA 510(k) clearance on 2017-12-26 under approval number K170138. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NEURONAUTE?
NEURONAUTE is a medical device that received FDA 510(k) clearance on 2017-12-26. It is manufactured by Bioserenity. The 510(k) number is K170138.
When was NEURONAUTE approved by the FDA?
NEURONAUTE received FDA 510(k) clearance on 2017-12-26, under approval number K170138.
What company makes NEURONAUTE?
NEURONAUTE is manufactured by Bioserenity.
What is the FDA product code for NEURONAUTE?
The FDA product code for NEURONAUTE is GWQ.
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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.