FDA 510(k)

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

K 號：K233985 · 2024-05-15

決定日期2024-05-15

產品代碼OLX

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：OLX）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：OLX）

官方來源