FDA 510(k)

RXS 1000

K 號：K202369 · 2021-09-15

決定日期2021-09-15

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

RXS 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Rolence Enterprise, Inc.. It received FDA 510(k) clearance on 2021-09-15 under 510(k) number K202369. 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 RXS 1000?

RXS 1000 is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Rolence Enterprise, Inc.. The 510(k) number is K202369.

When did RXS 1000 receive FDA 510(k) clearance?

RXS 1000 received FDA 510(k) clearance on 2021-09-15, under 510(k) number K202369.

Who is the listed applicant for RXS 1000?

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

What is the FDA product code for RXS 1000?

The FDA product code for RXS 1000 is MUH.

其他以 Rolence Enterprise, Inc. 為申請人之記錄

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相關器械（代碼：MUH）

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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