FDA 510(k)

Acclarix LX8 識別超音波系統

K 號：K160790 · 2016-04-04

決定日期2016-04-04

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Acclarix LX8 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K160790. 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 Acclarix LX8 Diagnostic Ultrasound System?

Acclarix LX8 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K160790.

When did Acclarix LX8 Diagnostic Ultrasound System receive FDA 510(k) clearance?

Acclarix LX8 Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-04-04, under 510(k) number K160790.

Who is the listed applicant for Acclarix LX8 Diagnostic Ultrasound System?

FDA 510(k) 記錄將 Edan Instruments, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Acclarix LX8 Diagnostic Ultrasound System?

The FDA product code for Acclarix LX8 Diagnostic Ultrasound System is IYN.

其他以 Edan Instruments, Inc. 為申請人之記錄

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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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