Vivid T8
K-Number: K160078 · 2016-03-10
Decision Date2016-03-10
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vivid T8 is a medical device manufactured by Ge Medical Systems Ultrasound and Primary Care Diagnotics, L. It received FDA 510(k) clearance on 2016-03-10 under approval number K160078. 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 T8?
Vivid T8 is a medical device that received FDA 510(k) clearance on 2016-03-10. It is manufactured by Ge Medical Systems Ultrasound and Primary Care Diagnotics, L. The 510(k) number is K160078.
When was Vivid T8 approved by the FDA?
Vivid T8 received FDA 510(k) clearance on 2016-03-10, under approval number K160078.
What company makes Vivid T8?
Vivid T8 is manufactured by Ge Medical Systems Ultrasound and Primary Care Diagnotics, L.
What is the FDA product code for Vivid T8?
The FDA product code for Vivid T8 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.