Versana Premier
K-Number: K182277 · 2018-11-21
Decision Date2018-11-21
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Versana Premier is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2018-11-21 under approval number K182277. 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 2018-11-21. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K182277.
When was Versana Premier approved by the FDA?
Versana Premier received FDA 510(k) clearance on 2018-11-21, under approval number K182277.
What company makes Versana Premier?
Versana Premier is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
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 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.