FDA 510(k)

睡眠裝置 G3

K 號：K202142 · 2020-10-29

決定日期2020-10-29

產品代碼OLZ

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

Sleepware G3 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2020-10-29 under 510(k) number K202142. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sleepware G3?

Sleepware G3 is a medical device that received FDA 510(k) clearance on 2020-10-29. The listed applicant is Respironics, Inc.. The 510(k) number is K202142.

When did Sleepware G3 receive FDA 510(k) clearance?

Sleepware G3 received FDA 510(k) clearance on 2020-10-29, under 510(k) number K202142.

Who is the listed applicant for Sleepware G3?

FDA 510(k) 記錄將Respironics, Inc.列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Sleepware G3?

The FDA product code for Sleepware G3 is OLZ.

其他以 Respironics, Inc. 為申請人之記錄

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相關器械（代碼：OLZ）

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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