6430 MyLabX75, 6430 MyLab XPro75
K-Number: K212021 · 2021-09-16
ApplicantEsaote, S.p.A.
Decision Date2021-09-16
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
6430 MyLabX75, 6430 MyLab XPro75 is a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2021-09-16 under approval number K212021. 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 6430 MyLabX75, 6430 MyLab XPro75?
6430 MyLabX75, 6430 MyLab XPro75 is a medical device that received FDA 510(k) clearance on 2021-09-16. It is manufactured by Esaote, S.p.A.. The 510(k) number is K212021.
When was 6430 MyLabX75, 6430 MyLab XPro75 approved by the FDA?
6430 MyLabX75, 6430 MyLab XPro75 received FDA 510(k) clearance on 2021-09-16, under approval number K212021.
What company makes 6430 MyLabX75, 6430 MyLab XPro75?
6430 MyLabX75, 6430 MyLab XPro75 is manufactured by Esaote, S.p.A..
What is the FDA product code for 6430 MyLabX75, 6430 MyLab XPro75?
The FDA product code for 6430 MyLabX75, 6430 MyLab XPro75 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.