FDA 510(k)

可攜式X光系統

K 號：K172928 · 2018-03-16

決定日期2018-03-16

產品代碼EHD

諮詢委員會DE

決定相當於

器材摘要

Portable X-ray System 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 2018-03-16 under 510(k) number K172928. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Portable X-ray System?

Portable X-ray System is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Rolence Enterprise, Inc.. The 510(k) number is K172928.

When did Portable X-ray System receive FDA 510(k) clearance?

Portable X-ray System received FDA 510(k) clearance on 2018-03-16, under 510(k) number K172928.

Who is the listed applicant for Portable X-ray System?

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 Portable X-ray System?

The FDA product code for Portable X-ray System is EHD.

其他以 Rolence Enterprise, Inc. 為申請人之記錄

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K202369RXS 1000

相關器械（代碼：EHD）

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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官方來源

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