FDA 510(k)

ARGUS PB-3000

K 號：K221056 · 2023-07-06

決定日期2023-07-06

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

ARGUS PB-3000 is the device name listed in this FDA 510(k) record. The listed applicant is Schiller AG. It received FDA 510(k) clearance on 2023-07-06 under 510(k) number K221056. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARGUS PB-3000?

ARGUS PB-3000 is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is Schiller AG. The 510(k) number is K221056.

When did ARGUS PB-3000 receive FDA 510(k) clearance?

ARGUS PB-3000 received FDA 510(k) clearance on 2023-07-06, under 510(k) number K221056.

Who is the listed applicant for ARGUS PB-3000?

FDA 510(k) 記錄將 Schiller AG 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for ARGUS PB-3000?

The FDA product code for ARGUS PB-3000 is MHX.

其他以 Schiller AG 為申請人之記錄

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相關器械（代碼：MHX）

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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