FDA 510(k)

夜鴉

K 號：K213463 · 2021-12-16

決定日期2021-12-16

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

NightOwl is the device name listed in this FDA 510(k) record. The listed applicant is Ectosense NV. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K213463. 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 NightOwl?

NightOwl is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Ectosense NV. The 510(k) number is K213463.

When did NightOwl receive FDA 510(k) clearance?

NightOwl received FDA 510(k) clearance on 2021-12-16, under 510(k) number K213463.

Who is the listed applicant for NightOwl?

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

What is the FDA product code for NightOwl?

The FDA product code for NightOwl is MNR.

其他以 Ectosense NV 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。

K220028夜鴉 K191031夜鴉

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。

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官方來源

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