6440 MyLabX90
K-Number: K230179 · 2023-11-29
ApplicantEsaote, S.p.A.
Decision Date2023-11-29
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
6440 MyLabX90 is a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2023-11-29 under approval number K230179. 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 6440 MyLabX90?
6440 MyLabX90 is a medical device that received FDA 510(k) clearance on 2023-11-29. It is manufactured by Esaote, S.p.A.. The 510(k) number is K230179.
When was 6440 MyLabX90 approved by the FDA?
6440 MyLabX90 received FDA 510(k) clearance on 2023-11-29, under approval number K230179.
What company makes 6440 MyLabX90?
6440 MyLabX90 is manufactured by Esaote, S.p.A..
What is the FDA product code for 6440 MyLabX90?
The FDA product code for 6440 MyLabX90 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.