FDA 510(k)

飛利浦 EPIQ 診斷超聲系統，飛利浦 Affiniti 診斷超聲系統

K 號：K212704 · 2021-09-24

決定日期2021-09-24

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2021-09-24 under 510(k) number K212704. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System?

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-09-24. The listed applicant is Philips Medical Systems. The 510(k) number is K212704.

When did Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System receive FDA 510(k) clearance?

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System received FDA 510(k) clearance on 2021-09-24, under 510(k) number K212704.

Who is the listed applicant for Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System?

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

What is the FDA product code for Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System?

The FDA product code for Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System is IYN.

其他以 Philips Medical Systems 為申請人之記錄

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相關器械（代碼：IYN）

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。

官方來源

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