FDA 510(k)

ANNE View, 中央樞紐

K 號：K242842 · 2025-01-08

決定日期2025-01-08

產品代碼MSX

諮詢委員會履歷

決定相當於

器材摘要

ANNE View, Central Hub 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 2025-01-08 under 510(k) number K242842. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ANNE View, Central Hub?

ANNE View, Central Hub is a medical device that received FDA 510(k) clearance on 2025-01-08. The listed applicant is Sibel Health, Inc.. The 510(k) number is K242842.

When did ANNE View, Central Hub receive FDA 510(k) clearance?

ANNE View, Central Hub received FDA 510(k) clearance on 2025-01-08, under 510(k) number K242842.

Who is the listed applicant for ANNE View, Central Hub?

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 View, Central Hub?

The FDA product code for ANNE View, Central Hub is MSX.

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 K240251ANNE 胸部 K240305ANNE 四肢 K223711ANNE 一體

相關器械（代碼：MSX）

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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