Versana Essential
K-Number: K223407 · 2023-02-15
Decision Date2023-02-15
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Versana Essential is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2023-02-15 under approval number K223407. 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 Essential?
Versana Essential is a medical device that received FDA 510(k) clearance on 2023-02-15. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K223407.
When was Versana Essential approved by the FDA?
Versana Essential received FDA 510(k) clearance on 2023-02-15, under approval number K223407.
What company makes Versana Essential?
Versana Essential is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Versana Essential?
The FDA product code for Versana Essential 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.