FDA 510(k)

ANNE 一體

K 號：K211305 · 2021-09-14

決定日期2021-09-14

產品代碼DRG

諮詢委員會履歷

決定相當於

器材摘要

ANNE One is the device name listed in this FDA 510(k) record. The listed applicant is Sibel, Inc.. It received FDA 510(k) clearance on 2021-09-14 under 510(k) number K211305. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ANNE One?

ANNE One is a medical device that received FDA 510(k) clearance on 2021-09-14. The listed applicant is Sibel, Inc.. The 510(k) number is K211305.

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

ANNE One received FDA 510(k) clearance on 2021-09-14, under 510(k) number K211305.

Who is the listed applicant for ANNE One?

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 One?

The FDA product code for ANNE One is DRG.

其他以 Sibel, Inc. 為申請人之記錄

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K221530ANNE 小兒 K220095ANNE 睡眠

相關器械（代碼：DRG）

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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