FDA 510(k)

ESG-300、APU-300、壓力減少器、MAPC探針

K 號：K180200 · 2018-04-26

決定日期2018-04-26

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

ESG-300, APU-300, Pressure Reducer, MAPC Probes is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2018-04-26 under 510(k) number K180200. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ESG-300, APU-300, Pressure Reducer, MAPC Probes?

ESG-300, APU-300, Pressure Reducer, MAPC Probes is a medical device that received FDA 510(k) clearance on 2018-04-26. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K180200.

When did ESG-300, APU-300, Pressure Reducer, MAPC Probes receive FDA 510(k) clearance?

ESG-300, APU-300, Pressure Reducer, MAPC Probes received FDA 510(k) clearance on 2018-04-26, under 510(k) number K180200.

Who is the listed applicant for ESG-300, APU-300, Pressure Reducer, MAPC Probes?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESG-300, APU-300, Pressure Reducer, MAPC Probes?

The FDA product code for ESG-300, APU-300, Pressure Reducer, MAPC Probes is GEI.

其他以 Olympus Winter & Ibe GmbH 為申請人之記錄

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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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官方來源

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