FDA 510(k)

TELIGEN 系統導航準備指示（TELIGEN 接觸探針，TELIGEN 清晰）

K 號：K223108 · 2023-01-19

決定日期2023-01-19

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

TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) 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 2023-01-19 under 510(k) number K223108. 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 TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)?

TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Medos International SARL. The 510(k) number is K223108.

When did TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) receive FDA 510(k) clearance?

TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) received FDA 510(k) clearance on 2023-01-19, under 510(k) number K223108.

Who is the listed applicant for TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)?

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 TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)?

The FDA product code for TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) is OLO.

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。

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