FDA 510(k)

Aco Apache 超聲系統

K 號：K231509 · 2023-10-24

決定日期2023-10-24

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Aco Apache Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Aco Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K231509. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aco Apache Ultrasound System?

Aco Apache Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Aco Healthcare Co., Ltd.. The 510(k) number is K231509.

When did Aco Apache Ultrasound System receive FDA 510(k) clearance?

Aco Apache Ultrasound System received FDA 510(k) clearance on 2023-10-24, under 510(k) number K231509.

Who is the listed applicant for Aco Apache Ultrasound System?

The FDA 510(k) record lists Aco Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aco Apache Ultrasound System?

The FDA product code for Aco Apache Ultrasound System is IYN.

其他以 Aco Healthcare Co., Ltd. 為申請人之記錄

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K211232Apache超聲波系統

相關器械（代碼：IYN）

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。

官方來源

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