FDA 510(k)

卡迪維特 AT-102 G2

K 號：K183425 · 2020-03-02

決定日期2020-03-02

產品代碼DPS

諮詢委員會履歷

決定相當於

器材摘要

CARDIOVIT AT-102 G2 is the device name listed in this FDA 510(k) record. The listed applicant is Schiller AG. It received FDA 510(k) clearance on 2020-03-02 under 510(k) number K183425. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CARDIOVIT AT-102 G2?

CARDIOVIT AT-102 G2 is a medical device that received FDA 510(k) clearance on 2020-03-02. The listed applicant is Schiller AG. The 510(k) number is K183425.

When did CARDIOVIT AT-102 G2 receive FDA 510(k) clearance?

CARDIOVIT AT-102 G2 received FDA 510(k) clearance on 2020-03-02, under 510(k) number K183425.

Who is the listed applicant for CARDIOVIT AT-102 G2?

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 CARDIOVIT AT-102 G2?

The FDA product code for CARDIOVIT AT-102 G2 is DPS.

其他以 Schiller AG 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。

K253562醫療設備名稱：medilogFD K221056ARGUS PB-3000 K170182心臟維他FT-1 K152043診斷站 DS20

相關器械（代碼：DPS）

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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