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FDA 510(k)

TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)

K-Number: K233985 · 2024-05-15

ApplicantMegin OY
Decision Date2024-05-15
Product CodeOLX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) is a medical device manufactured by Megin OY. It received FDA 510(k) clearance on 2024-05-15 under approval number K233985. The device is classified under product code OLX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)?

TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) is a medical device that received FDA 510(k) clearance on 2024-05-15. It is manufactured by Megin OY. The 510(k) number is K233985.

When was TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) approved by the FDA?

TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) received FDA 510(k) clearance on 2024-05-15, under approval number K233985.

What company makes TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)?

TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) is manufactured by Megin OY.

What is the FDA product code for TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)?

The FDA product code for TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) is OLX.

Related Devices (Code: OLX)

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.