Versana Balance
K-Number: K191792 · 2019-08-09
Decision Date2019-08-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Versana Balance 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 K191792. 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 Balance?
Versana Balance 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 K191792.
When was Versana Balance approved by the FDA?
Versana Balance received FDA 510(k) clearance on 2019-08-09, under approval number K191792.
What company makes Versana Balance?
Versana Balance is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Versana Balance?
The FDA product code for Versana Balance 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.