FDA 510(k)

Ysio Max

K 號：K181279 · 2018-06-13

決定日期2018-06-13

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

Ysio Max is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K181279. 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 Ysio Max?

Ysio Max is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K181279.

When did Ysio Max receive FDA 510(k) clearance?

Ysio Max received FDA 510(k) clearance on 2018-06-13, under 510(k) number K181279.

Who is the listed applicant for Ysio Max?

The FDA 510(k) record lists Siemens Medi Cal Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ysio Max?

The FDA product code for Ysio Max is KPR.

其他以 Siemens Medi Cal Solutions, Inc. 為申請人之記錄

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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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