Vscan Air
K-Number: K231301 · 2023-08-15
Decision Date2023-08-15
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vscan Air is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2023-08-15 under approval number K231301. 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 Vscan Air?
Vscan Air is a medical device that received FDA 510(k) clearance on 2023-08-15. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K231301.
When was Vscan Air approved by the FDA?
Vscan Air received FDA 510(k) clearance on 2023-08-15, under approval number K231301.
What company makes Vscan Air?
Vscan Air is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Vscan Air?
The FDA product code for Vscan Air 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.