MyLabSix CrystaLine
K-Number: K162290 · 2016-10-14
ApplicantEsaote, S.p.A.
Decision Date2016-10-14
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MyLabSix CrystaLine is a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2016-10-14 under approval number K162290. 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 MyLabSix CrystaLine?
MyLabSix CrystaLine is a medical device that received FDA 510(k) clearance on 2016-10-14. It is manufactured by Esaote, S.p.A.. The 510(k) number is K162290.
When was MyLabSix CrystaLine approved by the FDA?
MyLabSix CrystaLine received FDA 510(k) clearance on 2016-10-14, under approval number K162290.
What company makes MyLabSix CrystaLine?
MyLabSix CrystaLine is manufactured by Esaote, S.p.A..
What is the FDA product code for MyLabSix CrystaLine?
The FDA product code for MyLabSix CrystaLine 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.