FDA 510(k)

XVISION-525、HORIZON、HI-300、HI-500、SATURN-F PF32、SATURN-F PF40、SATURN-F PF50

K 號：K230800 · 2023-11-02

決定日期2023-11-02

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 is the device name listed in this FDA 510(k) record. The listed applicant is GEMSS HEALTHCARE CO., LTD.. It received FDA 510(k) clearance on 2023-11-02 under 510(k) number K230800. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50?

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 is a medical device that received FDA 510(k) clearance on 2023-11-02. The listed applicant is GEMSS HEALTHCARE CO., LTD.. The 510(k) number is K230800.

When did XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 receive FDA 510(k) clearance?

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 received FDA 510(k) clearance on 2023-11-02, under 510(k) number K230800.

Who is the listed applicant for XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50?

FDA 510(k) 記錄將 GEMSS HEALTHCARE CO., LTD. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50?

The FDA product code for XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 is KPR.

其他以 GEMSS HEALTHCARE CO., LTD. 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。

K260236XLITE K233200XPLUS 35 系列型號 (XPLUS 35, XPLUS 35FD)

相關器械（代碼：KPR）

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。

K260227EXSYS DEXi (EXSYS DEXi-S40S)；EXSYS DEXi (EXSYS DEXi-S40P)；EXSYS DEXi (EXSYS DEXi-S40T)；EXSYS DEXi (EXSYS DEXi-S50H)DRTECH Corporation K260488MULTIX 震擊；MULTIX 震擊 CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE 雙用設備Jpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus 電影系統，DRX-Compass 流動電影系統，Lux HD 35 探測器，Lux HD 43 探測器Carestream Health

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。