Venue Fit
K-Number: K203137 · 2020-12-29
Decision Date2020-12-29
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Venue Fit is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2020-12-29 under approval number K203137. 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 Fit?
Venue Fit is a medical device that received FDA 510(k) clearance on 2020-12-29. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K203137.
When was Venue Fit approved by the FDA?
Venue Fit received FDA 510(k) clearance on 2020-12-29, under approval number K203137.
What company makes Venue Fit?
Venue Fit is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Venue Fit?
The FDA product code for Venue Fit 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.