Venue
K-Number: K180599 · 2018-05-02
Decision Date2018-05-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Venue is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2018-05-02 under approval number K180599. 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?
Venue is a medical device that received FDA 510(k) clearance on 2018-05-02. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K180599.
When was Venue approved by the FDA?
Venue received FDA 510(k) clearance on 2018-05-02, under approval number K180599.
What company makes Venue?
Venue is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Venue?
The FDA product code for Venue 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.