FDA 510(k)

Sonosite PX 超聲系統

K 號：K200964 · 2020-05-08

決定日期2020-05-08

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Sonosite PX Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2020-05-08 under 510(k) number K200964. 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 Sonosite PX Ultrasound System?

Sonosite PX Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-05-08. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K200964.

When did Sonosite PX Ultrasound System receive FDA 510(k) clearance?

Sonosite PX Ultrasound System received FDA 510(k) clearance on 2020-05-08, under 510(k) number K200964.

Who is the listed applicant for Sonosite PX Ultrasound System?

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

What is the FDA product code for Sonosite PX Ultrasound System?

The FDA product code for Sonosite PX Ultrasound System is IYN.

其他以 FUJIFILM Sonosite, 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。

K260595Sonosite iLOOK 超聲波系統 K253448Sonosite MT 超聲系統 K251106Sonosite LX 及 Sonosite PX 超聲系統 K251830Sonosite LX 超聲系統 K233597Sonosite LX 超聲系統 K213763Sonosite PX 超聲系統

查看所有 19 項裝置 →

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

在 FDA 資料庫中查看 →

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