Vivid E80/ Vivid E90/ Vivid E95
K-Number: K202658 · 2021-03-05
Decision Date2021-03-05
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vivid E80/ Vivid E90/ Vivid E95 is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2021-03-05 under approval number K202658. 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 Vivid E80/ Vivid E90/ Vivid E95?
Vivid E80/ Vivid E90/ Vivid E95 is a medical device that received FDA 510(k) clearance on 2021-03-05. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K202658.
When was Vivid E80/ Vivid E90/ Vivid E95 approved by the FDA?
Vivid E80/ Vivid E90/ Vivid E95 received FDA 510(k) clearance on 2021-03-05, under approval number K202658.
What company makes Vivid E80/ Vivid E90/ Vivid E95?
Vivid E80/ Vivid E90/ Vivid E95 is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Vivid E80/ Vivid E90/ Vivid E95?
The FDA product code for Vivid E80/ Vivid E90/ Vivid E95 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.