FDA 510(k)

RIOScan (RPS500)

K 號：K160788 · 2016-04-15

決定日期2016-04-15

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

RIOScan (RPS500) is the device name listed in this FDA 510(k) record. The listed applicant is Ray Co., Ltd.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K160788. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RIOScan (RPS500)?

RIOScan (RPS500) is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Ray Co., Ltd.. The 510(k) number is K160788.

When did RIOScan (RPS500) receive FDA 510(k) clearance?

RIOScan (RPS500) received FDA 510(k) clearance on 2016-04-15, under 510(k) number K160788.

Who is the listed applicant for RIOScan (RPS500)?

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

What is the FDA product code for RIOScan (RPS500)?

The FDA product code for RIOScan (RPS500) is MUH.

其他以 Ray Co., Ltd. 為申請人之記錄

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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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