FDA 510(k)

ANNE 睡眠

K 號：K220095 · 2022-07-11

決定日期2022-07-11

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

ANNE Sleep is the device name listed in this FDA 510(k) record. The listed applicant is Sibel, Inc.. It received FDA 510(k) clearance on 2022-07-11 under 510(k) number K220095. 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 ANNE Sleep?

ANNE Sleep is a medical device that received FDA 510(k) clearance on 2022-07-11. The listed applicant is Sibel, Inc.. The 510(k) number is K220095.

When did ANNE Sleep receive FDA 510(k) clearance?

ANNE Sleep received FDA 510(k) clearance on 2022-07-11, under 510(k) number K220095.

Who is the listed applicant for ANNE Sleep?

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

What is the FDA product code for ANNE Sleep?

The FDA product code for ANNE Sleep is MNR.

其他以 Sibel, Inc. 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。

K221530ANNE 小兒 K211305ANNE 一體

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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