visor2 system
K-Number: K210109 · 2022-04-08
Decision Date2022-04-08
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
visor2 system is a medical device manufactured by Eemagine Medical Imaging Solutions GmbH. It received FDA 510(k) clearance on 2022-04-08 under approval number K210109. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the visor2 system?
visor2 system is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Eemagine Medical Imaging Solutions GmbH. The 510(k) number is K210109.
When was visor2 system approved by the FDA?
visor2 system received FDA 510(k) clearance on 2022-04-08, under approval number K210109.
What company makes visor2 system?
visor2 system is manufactured by Eemagine Medical Imaging Solutions GmbH.
What is the FDA product code for visor2 system?
The FDA product code for visor2 system is HAW.
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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.