FDA 510(k)

外傷性腦部損傷（TBI）測試

K 號：K223602 · 2023-03-02

決定日期2023-03-02

產品代碼QAT

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

Traumatic brain injury (TBI) test is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K223602. The device is classified under product code QAT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Traumatic brain injury (TBI) test?

Traumatic brain injury (TBI) test is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Abbott Laboratories. The 510(k) number is K223602.

When did Traumatic brain injury (TBI) test receive FDA 510(k) clearance?

Traumatic brain injury (TBI) test received FDA 510(k) clearance on 2023-03-02, under 510(k) number K223602.

Who is the listed applicant for Traumatic brain injury (TBI) test?

FDA 510(k) 記錄中將阿培爾實驗室列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Traumatic brain injury (TBI) test?

The FDA product code for Traumatic brain injury (TBI) test is QAT.