FDA 510(k)

裕米森C1200 CRP

K 號：K192028 · 2020-06-25

決定日期2020-06-25

產品代碼DCK

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

Yumizen C1200 CRP is the device name listed in this FDA 510(k) record. The listed applicant is HORIBA ABX SAS. It received FDA 510(k) clearance on 2020-06-25 under 510(k) number K192028. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Yumizen C1200 CRP?

Yumizen C1200 CRP is a medical device that received FDA 510(k) clearance on 2020-06-25. The listed applicant is HORIBA ABX SAS. The 510(k) number is K192028.

When did Yumizen C1200 CRP receive FDA 510(k) clearance?

Yumizen C1200 CRP received FDA 510(k) clearance on 2020-06-25, under 510(k) number K192028.

Who is the listed applicant for Yumizen C1200 CRP?

FDA 510(k) 記錄將 HORIBA ABX SAS 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Yumizen C1200 CRP?

The FDA product code for Yumizen C1200 CRP is DCK.