FDA 510(k)

ANNE 小兒

K 號：K221530 · 2022-11-22

決定日期2022-11-22

產品代碼DRG

諮詢委員會履歷

決定相當於

器材摘要

ANNE Pediatric is the device name listed in this FDA 510(k) record. The listed applicant is Sibel, Inc.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K221530. 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 Pediatric?

ANNE Pediatric is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Sibel, Inc.. The 510(k) number is K221530.

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

ANNE Pediatric received FDA 510(k) clearance on 2022-11-22, under 510(k) number K221530.

Who is the listed applicant for ANNE Pediatric?

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 Pediatric?

The FDA product code for ANNE Pediatric is DRG.

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。

K220095ANNE 睡眠 K211305ANNE 一體

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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