Vivid E80, Vivid E90, Vivid E95
K-Number: K181685 · 2018-10-25
Decision Date2018-10-25
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 2018-10-25 under approval number K181685. 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 2018-10-25. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K181685.
When was Vivid E80, Vivid E90, Vivid E95 approved by the FDA?
Vivid E80, Vivid E90, Vivid E95 received FDA 510(k) clearance on 2018-10-25, under approval number K181685.
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.
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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.