FDA 510(k)

DMX

K 號：K223550 · 2023-04-10

決定日期2023-04-10

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

DMX is the device name listed in this FDA 510(k) record. The listed applicant is Del Medical, Inc.. It received FDA 510(k) clearance on 2023-04-10 under 510(k) number K223550. 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 DMX?

DMX is a medical device that received FDA 510(k) clearance on 2023-04-10. The listed applicant is Del Medical, Inc.. The 510(k) number is K223550.

When did DMX receive FDA 510(k) clearance?

DMX received FDA 510(k) clearance on 2023-04-10, under 510(k) number K223550.

Who is the listed applicant for DMX?

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

What is the FDA product code for DMX?

The FDA product code for DMX is KPR.

其他以 Del Medical, Inc. 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。

K173018MDR17移動直接射線攝影系統

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

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