Axonpen, Axonmonitor, Axonbox, Tablet
K-Number: K201308 · 2020-11-27
ApplicantClearmind Biomedical
Decision Date2020-11-27
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Axonpen, Axonmonitor, Axonbox, Tablet is a medical device manufactured by Clearmind Biomedical. It received FDA 510(k) clearance on 2020-11-27 under approval number K201308. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Axonpen, Axonmonitor, Axonbox, Tablet?
Axonpen, Axonmonitor, Axonbox, Tablet is a medical device that received FDA 510(k) clearance on 2020-11-27. It is manufactured by Clearmind Biomedical. The 510(k) number is K201308.
When was Axonpen, Axonmonitor, Axonbox, Tablet approved by the FDA?
Axonpen, Axonmonitor, Axonbox, Tablet received FDA 510(k) clearance on 2020-11-27, under approval number K201308.
What company makes Axonpen, Axonmonitor, Axonbox, Tablet?
Axonpen, Axonmonitor, Axonbox, Tablet is manufactured by Clearmind Biomedical.
What is the FDA product code for Axonpen, Axonmonitor, Axonbox, Tablet?
The FDA product code for Axonpen, Axonmonitor, Axonbox, Tablet is GWG.
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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.