6400 Ultrasound System (MyLabX6, MyLabX7)
K-Number: K190989 · 2019-05-10
ApplicantEsaote, S.p.A.
Decision Date2019-05-10
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
6400 Ultrasound System (MyLabX6, MyLabX7) is a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2019-05-10 under approval number K190989. 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 6400 Ultrasound System (MyLabX6, MyLabX7)?
6400 Ultrasound System (MyLabX6, MyLabX7) is a medical device that received FDA 510(k) clearance on 2019-05-10. It is manufactured by Esaote, S.p.A.. The 510(k) number is K190989.
When was 6400 Ultrasound System (MyLabX6, MyLabX7) approved by the FDA?
6400 Ultrasound System (MyLabX6, MyLabX7) received FDA 510(k) clearance on 2019-05-10, under approval number K190989.
What company makes 6400 Ultrasound System (MyLabX6, MyLabX7)?
6400 Ultrasound System (MyLabX6, MyLabX7) is manufactured by Esaote, S.p.A..
What is the FDA product code for 6400 Ultrasound System (MyLabX6, MyLabX7)?
The FDA product code for 6400 Ultrasound System (MyLabX6, MyLabX7) 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.