FDA 510(k)

奧內拉睡眠測試系統（Onera STS）

K 號：K223573 · 2023-08-18

決定日期2023-08-18

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

Onera Sleep Test System (Onera STS) is the device name listed in this FDA 510(k) record. The listed applicant is Onera B.V.. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K223573. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Onera Sleep Test System (Onera STS)?

Onera Sleep Test System (Onera STS) is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Onera B.V.. The 510(k) number is K223573.

When did Onera Sleep Test System (Onera STS) receive FDA 510(k) clearance?

Onera Sleep Test System (Onera STS) received FDA 510(k) clearance on 2023-08-18, under 510(k) number K223573.

Who is the listed applicant for Onera Sleep Test System (Onera STS)?

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

What is the FDA product code for Onera Sleep Test System (Onera STS)?

The FDA product code for Onera Sleep Test System (Onera STS) is MNR.

其他以 Onera B.V. 為申請人之記錄

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。

K253668Onera SleepMap (SLEEPMAP)K243220Onera STS 2 (Onera STS 2)K210593奧內拉睡眠測試系統（Onera STS）

相關器械（代碼：MNR）

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。

K260949一次性睡眠監測帶（CNSAC）CNSAC Medshop GmbH K254042觀察者PAT SWItamar Medical , Ltd.K260050WRAP系統Huneo, LLC K253148RX-1 睡眠Vivaquant, Inc. Dba Rhythm Express K252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

官方來源

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