FDA 510(k)

飛利浦藍控

K 號：K171055 · 2017-07-06

決定日期2017-07-06

產品代碼ONE

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Philips BlueControl is the device name listed in this FDA 510(k) record. The listed applicant is Philips Electronics Nederland B.V.. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K171055. The device is classified under product code ONE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Philips BlueControl?

Philips BlueControl is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Philips Electronics Nederland B.V.. The 510(k) number is K171055.

When did Philips BlueControl receive FDA 510(k) clearance?

Philips BlueControl received FDA 510(k) clearance on 2017-07-06, under 510(k) number K171055.

Who is the listed applicant for Philips BlueControl?

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

What is the FDA product code for Philips BlueControl?

The FDA product code for Philips BlueControl is ONE.

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

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。

K192259飛利浦 IntelliSite 病理解決方案

相關器械（代碼：ONE）

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。

K250224handLITE (TN19S)iSMART Developments, Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。