Neo
K-Number: K192889 · 2020-01-30
Decision Date2020-01-30
Product CodeOMA
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Neo is a medical device manufactured by Eemagine Medical Imaging Solutions GmbH. It received FDA 510(k) clearance on 2020-01-30 under approval number K192889. The device is classified under product code OMA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Neo?
Neo is a medical device that received FDA 510(k) clearance on 2020-01-30. It is manufactured by Eemagine Medical Imaging Solutions GmbH. The 510(k) number is K192889.
When was Neo approved by the FDA?
Neo received FDA 510(k) clearance on 2020-01-30, under approval number K192889.
What company makes Neo?
Neo is manufactured by Eemagine Medical Imaging Solutions GmbH.
What is the FDA product code for Neo?
The FDA product code for Neo is OMA.
Other Devices by Eemagine Medical Imaging Solutions GmbH
Related Devices (Code: OMA)
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.