Versana Active
K-Number: K191798 · 2019-08-09
Decision Date2019-08-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Versana Active is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2019-08-09 under approval number K191798. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Versana Active?
Versana Active is a medical device that received FDA 510(k) clearance on 2019-08-09. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K191798.
When was Versana Active approved by the FDA?
Versana Active received FDA 510(k) clearance on 2019-08-09, under approval number K191798.
What company makes Versana Active?
Versana Active is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Versana Active?
The FDA product code for Versana Active is IYN.
Other Devices by GE Medical Systems Ultrasound and Primary Care Diagnostics
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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.