FDA 510(k)

Allura Xper FD series and Allura Xper OR Table series

K 號：K161563 · 2016-07-29

申請人Philips Medical Systems Nederland B.V.

決定日期2016-07-29

產品代碼OWB

諮詢委員會RA

決定Substantially Equivalent

器材摘要

Allura Xper FD series and Allura Xper OR Table series is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K161563. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Allura Xper FD series and Allura Xper OR Table series?

Allura Xper FD series and Allura Xper OR Table series is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K161563.

When did Allura Xper FD series and Allura Xper OR Table series receive FDA 510(k) clearance?

Allura Xper FD series and Allura Xper OR Table series received FDA 510(k) clearance on 2016-07-29, under 510(k) number K161563.

Who is the listed applicant for Allura Xper FD series and Allura Xper OR Table series?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Allura Xper FD series and Allura Xper OR Table series?

The FDA product code for Allura Xper FD series and Allura Xper OR Table series is OWB.

其他以 Philips Medical Systems Nederland B.V. 為申請人之記錄

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相關器械（代碼：OWB）

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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