FDA 510(k)

Ablamap 軟體

K 號：K203084 · 2021-08-31

決定日期2021-08-31

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

Ablamap Software is the device name listed in this FDA 510(k) record. The listed applicant is Ablacon, Inc.. It received FDA 510(k) clearance on 2021-08-31 under 510(k) number K203084. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ablamap Software?

Ablamap Software is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Ablacon, Inc.. The 510(k) number is K203084.

When did Ablamap Software receive FDA 510(k) clearance?

Ablamap Software received FDA 510(k) clearance on 2021-08-31, under 510(k) number K203084.

Who is the listed applicant for Ablamap Software?

The FDA 510(k) record lists Ablacon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ablamap Software?

The FDA product code for Ablamap Software is DQK.

其他以 Ablacon, 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。

K230008Ablamap® 系統 K223666Ablacath™ 繪製導管

相關器械（代碼：DQK）

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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