Venue
K-Number: K170714 · 2017-06-21
Decision Date2017-06-21
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Venue is a medical device manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2017-06-21 under approval number K170714. 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 2017-06-21. It is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K170714.
When was Venue approved by the FDA?
Venue received FDA 510(k) clearance on 2017-06-21, under approval number K170714.
What company makes Venue?
Venue is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.
What is the FDA product code for Venue?
The FDA product code for Venue is IYN.
Other Devices by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
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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.