FDA 510(k)

PROMO

K 號：K251443 · 2025-08-22

決定日期2025-08-22

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

PROMO is the device name listed in this FDA 510(k) record. The listed applicant is DRGEM Corporation. It received FDA 510(k) clearance on 2025-08-22 under 510(k) number K251443. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PROMO?

PROMO is a medical device that received FDA 510(k) clearance on 2025-08-22. The listed applicant is DRGEM Corporation. The 510(k) number is K251443.

When did PROMO receive FDA 510(k) clearance?

PROMO received FDA 510(k) clearance on 2025-08-22, under 510(k) number K251443.

Who is the listed applicant for PROMO?

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

What is the FDA product code for PROMO?

The FDA product code for PROMO is IZL.

其他以 DRGEM Corporation 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。

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相關器械（代碼：IZL）

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。

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058攜帶式DR影像系統Shantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO移動X光系統（型號：RAYMO）DRGEM Corporation K253185Lux HD 檢測器，DRX-LC 檢測器，DRX-Revolution 移動 X 光系統Carestream Health K253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

官方來源

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