FDA 510(k)

CAS-One 紅外線

K 號：K152473 · 2016-01-20

決定日期2016-01-20

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

CAS-One IR is the device name listed in this FDA 510(k) record. The listed applicant is Cascination AG. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K152473. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CAS-One IR?

CAS-One IR is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Cascination AG. The 510(k) number is K152473.

When did CAS-One IR receive FDA 510(k) clearance?

CAS-One IR received FDA 510(k) clearance on 2016-01-20, under 510(k) number K152473.

Who is the listed applicant for CAS-One IR?

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

What is the FDA product code for CAS-One IR?

The FDA product code for CAS-One IR is JAK.

其他以 Cascination AG 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：JAK）

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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官方來源

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