Optimus Neuro System
K-Number: K183352 · 2019-01-02
ApplicantOsteonic Co., Ltd.
Decision Date2019-01-02
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Optimus Neuro System is a medical device manufactured by Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2019-01-02 under approval number K183352. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Optimus Neuro System?
Optimus Neuro System is a medical device that received FDA 510(k) clearance on 2019-01-02. It is manufactured by Osteonic Co., Ltd.. The 510(k) number is K183352.
When was Optimus Neuro System approved by the FDA?
Optimus Neuro System received FDA 510(k) clearance on 2019-01-02, under approval number K183352.
What company makes Optimus Neuro System?
Optimus Neuro System is manufactured by Osteonic Co., Ltd..
What is the FDA product code for Optimus Neuro System?
The FDA product code for Optimus Neuro System is GWO.
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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.