FDA 510(k)

STAR 65

K 號：K172147 · 2018-05-25

決定日期2018-05-25

產品代碼MWI

諮詢委員會履歷

決定相當於

器材摘要

STAR 65 is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies Pvt, Ltd.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K172147. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STAR 65?

STAR 65 is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Skanray Technologies Pvt, Ltd.. The 510(k) number is K172147.

When did STAR 65 receive FDA 510(k) clearance?

STAR 65 received FDA 510(k) clearance on 2018-05-25, under 510(k) number K172147.

Who is the listed applicant for STAR 65?

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

What is the FDA product code for STAR 65?

The FDA product code for STAR 65 is MWI.

相關器械（代碼：MWI）

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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