FDA 510(k)

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

K-Nummer: K233985 · 2024-05-15

AntragstellerMegin OY

Entscheidungsdatum2024-05-15

ProduktcodeOLX

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

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

Häufig gestellte Fragen

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. The listed applicant is Megin OY. The 510(k) number is K233985.

When did TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) receive FDA 510(k) clearance?

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

Who is the listed applicant for TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)?

The FDA 510(k) record lists Megin OY as the applicant. This does not by itself establish the device manufacturer.

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.

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Verwandte Geräte (Code: OLX)

K260563CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND Neuro K252565PreOp v3Clouds of Care K250239NeuroMatchLVIS Corporation K241513SourcererBrain Electrophysiology Laboratory Company, LLC K210199RICOH MEGRicoh Company, Ltd.K201910EZTrackNeurologic, LLC

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