Venue GO
K-Number: K183362 · 2019-01-28
Decision Date2019-01-28
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Venue GO is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2019-01-28 under approval number K183362. 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 Venue GO?
Venue GO is a medical device that received FDA 510(k) clearance on 2019-01-28. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K183362.
When was Venue GO approved by the FDA?
Venue GO received FDA 510(k) clearance on 2019-01-28, under approval number K183362.
What company makes Venue GO?
Venue GO is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Venue GO?
The FDA product code for Venue GO 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.