FDA 510(k)

富士通超音波處理器SP-900及富士通超音波探針PB2020-M

K 號：K171207 · 2018-01-11

決定日期2018-01-11

產品代碼ODG

諮詢委員會GU

決定相當於

器材摘要

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K171207. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M?

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K171207.

When did FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M receive FDA 510(k) clearance?

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M received FDA 510(k) clearance on 2018-01-11, under 510(k) number K171207.

Who is the listed applicant for FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M?

The FDA product code for FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is ODG.

其他以 Fujifilm Medical Systems U.S.A, Inc. 為申請人之記錄

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相關器械（代碼：ODG）

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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