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FDA 510(k)

病人狀態引擎

K 號：K172329 · 2018-04-23

申請人Isansys Lifecare, Ltd.
決定日期2018-04-23
產品代碼DRG
諮詢委員會履歷
決定相當於

器材摘要

Patient Status Engine is the device name listed in this FDA 510(k) record. The listed applicant is Isansys Lifecare, Ltd.. It received FDA 510(k) clearance on 2018-04-23 under 510(k) number K172329. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Patient Status Engine?

Patient Status Engine is a medical device that received FDA 510(k) clearance on 2018-04-23. The listed applicant is Isansys Lifecare, Ltd.. The 510(k) number is K172329.

When did Patient Status Engine receive FDA 510(k) clearance?

Patient Status Engine received FDA 510(k) clearance on 2018-04-23, under 510(k) number K172329.

Who is the listed applicant for Patient Status Engine?

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

What is the FDA product code for Patient Status Engine?

The FDA product code for Patient Status Engine is DRG.

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官方來源

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