FDA 510(k)

SOMNOscreen plus

K 號：K201054 · 2020-08-12

決定日期2020-08-12

產品代碼OLV

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

SOMNOscreen plus is the device name listed in this FDA 510(k) record. The listed applicant is Somnomedics GmbH. It received FDA 510(k) clearance on 2020-08-12 under 510(k) number K201054. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SOMNOscreen plus?

SOMNOscreen plus is a medical device that received FDA 510(k) clearance on 2020-08-12. The listed applicant is Somnomedics GmbH. The 510(k) number is K201054.

When did SOMNOscreen plus receive FDA 510(k) clearance?

SOMNOscreen plus received FDA 510(k) clearance on 2020-08-12, under 510(k) number K201054.

Who is the listed applicant for SOMNOscreen plus?

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

What is the FDA product code for SOMNOscreen plus?

The FDA product code for SOMNOscreen plus is OLV.

其他以 Somnomedics GmbH 為申請人之記錄

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相關器械（代碼：OLV）

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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