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FDA 510(k)

Allura Xper R9

K 號：K162148 · 2016-11-23

申請人Philips Medical Systems Nethrlands BV
決定日期2016-11-23
產品代碼OWB
諮詢委員會RA
決定相當於

器材摘要

Allura Xper R9 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nethrlands BV. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K162148. 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 R9?

Allura Xper R9 is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Philips Medical Systems Nethrlands BV. The 510(k) number is K162148.

When did Allura Xper R9 receive FDA 510(k) clearance?

Allura Xper R9 received FDA 510(k) clearance on 2016-11-23, under 510(k) number K162148.

Who is the listed applicant for Allura Xper R9?

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

What is the FDA product code for Allura Xper R9?

The FDA product code for Allura Xper R9 is OWB.

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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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官方來源

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