Voluson SWIFT, Voluson SWIFT+
K-Number: K201828 · 2020-10-11
Decision Date2020-10-11
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Voluson SWIFT, Voluson SWIFT+ is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2020-10-11 under approval number K201828. 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 Voluson SWIFT, Voluson SWIFT+?
Voluson SWIFT, Voluson SWIFT+ is a medical device that received FDA 510(k) clearance on 2020-10-11. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K201828.
When was Voluson SWIFT, Voluson SWIFT+ approved by the FDA?
Voluson SWIFT, Voluson SWIFT+ received FDA 510(k) clearance on 2020-10-11, under approval number K201828.
What company makes Voluson SWIFT, Voluson SWIFT+?
Voluson SWIFT, Voluson SWIFT+ is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Voluson SWIFT, Voluson SWIFT+?
The FDA product code for Voluson SWIFT, Voluson SWIFT+ 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.