FDA 510(k)

クロスナビ・ナビゲーション対応機器およびユナス・ナビゲーションアレイ

K番号: K241893 · 2024-09-16

決定日2024-09-16

製品コードOLO

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2024-09-16 under 510(k) number K241893. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays?

CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays is a medical device that received FDA 510(k) clearance on 2024-09-16. The listed applicant is Medos International SARL. The 510(k) number is K241893.

When did CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays receive FDA 510(k) clearance?

CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays received FDA 510(k) clearance on 2024-09-16, under 510(k) number K241893.

Who is the listed applicant for CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays?

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

What is the FDA product code for CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays?

The FDA product code for CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays is OLO.

申請者としてMedos International SARLを記載するその他の記録

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