FDA 510(k)

白金dRF影像系統

K 號：K160301 · 2016-03-04

決定日期2016-03-04

產品代碼JAA

諮詢委員會RA

決定相當於

器材摘要

Platinum dRF Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Apelem-Dms Group. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K160301. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Platinum dRF Imaging System?

Platinum dRF Imaging System is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Apelem-Dms Group. The 510(k) number is K160301.

When did Platinum dRF Imaging System receive FDA 510(k) clearance?

Platinum dRF Imaging System received FDA 510(k) clearance on 2016-03-04, under 510(k) number K160301.

Who is the listed applicant for Platinum dRF Imaging System?

The FDA 510(k) record lists Apelem-Dms Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Platinum dRF Imaging System?

The FDA product code for Platinum dRF Imaging System is JAA.

其他以 Apelem-Dms Group 為申請人之記錄

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K203010白金dRF影像系統

相關器械（代碼：JAA）

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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