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FDA 510(k)

Magnifico Open (100009900); Magnifico MSK ( 100009910)

K-Number: K241133 · 2024-06-26

Decision Date2024-06-26
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Magnifico Open (100009900); Magnifico MSK ( 100009910) is a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2024-06-26 under approval number K241133. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Magnifico Open (100009900); Magnifico MSK ( 100009910)?

Magnifico Open (100009900); Magnifico MSK ( 100009910) is a medical device that received FDA 510(k) clearance on 2024-06-26. It is manufactured by Esaote, S.p.A.. The 510(k) number is K241133.

When was Magnifico Open (100009900); Magnifico MSK ( 100009910) approved by the FDA?

Magnifico Open (100009900); Magnifico MSK ( 100009910) received FDA 510(k) clearance on 2024-06-26, under approval number K241133.

What company makes Magnifico Open (100009900); Magnifico MSK ( 100009910)?

Magnifico Open (100009900); Magnifico MSK ( 100009910) is manufactured by Esaote, S.p.A..

What is the FDA product code for Magnifico Open (100009900); Magnifico MSK ( 100009910)?

The FDA product code for Magnifico Open (100009900); Magnifico MSK ( 100009910) is LNH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.