Venue
K-Number: K220851 · 2022-06-27
ApplicantGE Medical Systems
Decision Date2022-06-27
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Venue is a medical device manufactured by GE Medical Systems. It received FDA 510(k) clearance on 2022-06-27 under approval number K220851. 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 2022-06-27. It is manufactured by GE Medical Systems. The 510(k) number is K220851.
When was Venue approved by the FDA?
Venue received FDA 510(k) clearance on 2022-06-27, under approval number K220851.
What company makes Venue?
Venue is manufactured by GE Medical Systems.
What is the FDA product code for Venue?
The FDA product code for Venue is IYN.
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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.