Versana Premier
K-Number: K200138 · 2020-07-01
ApplicantGe Medical Systems Ultrasound And
Decision Date2020-07-01
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Versana Premier is a medical device manufactured by Ge Medical Systems Ultrasound And. It received FDA 510(k) clearance on 2020-07-01 under approval number K200138. 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 Premier?
Versana Premier is a medical device that received FDA 510(k) clearance on 2020-07-01. It is manufactured by Ge Medical Systems Ultrasound And. The 510(k) number is K200138.
When was Versana Premier approved by the FDA?
Versana Premier received FDA 510(k) clearance on 2020-07-01, under approval number K200138.
What company makes Versana Premier?
Versana Premier is manufactured by Ge Medical Systems Ultrasound And.
What is the FDA product code for Versana Premier?
The FDA product code for Versana Premier is IYN.
Other Devices by Ge Medical Systems Ultrasound And
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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.