FDA 510(k)

ArtPix 行動式 EZ2GO

K 號：K162224 · 2016-09-22

決定日期2016-09-22

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

ArtPix Mobile EZ2GO is the device name listed in this FDA 510(k) record. The listed applicant is Cmt Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K162224. 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 ArtPix Mobile EZ2GO?

ArtPix Mobile EZ2GO is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Cmt Medical Technologies, Ltd.. The 510(k) number is K162224.

When did ArtPix Mobile EZ2GO receive FDA 510(k) clearance?

ArtPix Mobile EZ2GO received FDA 510(k) clearance on 2016-09-22, under 510(k) number K162224.

Who is the listed applicant for ArtPix Mobile EZ2GO?

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

What is the FDA product code for ArtPix Mobile EZ2GO?

The FDA product code for ArtPix Mobile EZ2GO is KPR.

其他以 Cmt Medical Technologies, Ltd. 為申請人之記錄

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K202235ArtPIX DRF

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

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