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FDA 510(k)

和諧導航準備儀器

K 號:K260240 · 2026-03-27

決定日期2026-03-27
產品代碼OLO
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

SYMPHONY Navigation Ready Instruments 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 2026-03-27 under 510(k) number K260240. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SYMPHONY Navigation Ready Instruments?

SYMPHONY Navigation Ready Instruments is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Medos International SARL. The 510(k) number is K260240.

When did SYMPHONY Navigation Ready Instruments receive FDA 510(k) clearance?

SYMPHONY Navigation Ready Instruments received FDA 510(k) clearance on 2026-03-27, under 510(k) number K260240.

Who is the listed applicant for SYMPHONY Navigation Ready Instruments?

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 SYMPHONY Navigation Ready Instruments?

The FDA product code for SYMPHONY Navigation Ready Instruments is OLO.

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其他以 Medos International SARL 為申請人之記錄

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相關器械(代碼:OLO)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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