FDA 510(k)

ANNE 一體

K 號：K223711 · 2023-08-10

決定日期2023-08-10

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 Health, Inc.. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K223711. 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 2023-08-10. The listed applicant is Sibel Health, Inc.. The 510(k) number is K223711.

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

ANNE One received FDA 510(k) clearance on 2023-08-10, under 510(k) number K223711.

Who is the listed applicant for ANNE One?

The FDA 510(k) record lists Sibel Health, 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 Health, 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。

K253021ANNE 妇科 K242842ANNE View, 中央樞紐 K240251ANNE 胸部 K240305ANNE 四肢

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。

K261569UbiqVue™ 2AYe 心臟系統 (UX2253)Lifesignals, Inc.K252984Perin醫療系統（PHD80060-2）Perin Health Devices, LLC K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259遠端復健 Aermos 心肺復健設備The ScottCare Corporation K243837iBSMIorbit Digital Technologies Private Limited K242018UbiqVue™ 2A 多參數系統 (UX2550)Lifesignals, Inc.

官方來源

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