FDA 510(k)

SmartUs EXT-1M/3M

K 號：K163121 · 2017-08-10

決定日期2017-08-10

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

SmartUs EXT-1M/3M is the device name listed in this FDA 510(k) record. The listed applicant is Telemed. It received FDA 510(k) clearance on 2017-08-10 under 510(k) number K163121. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SmartUs EXT-1M/3M?

SmartUs EXT-1M/3M is a medical device that received FDA 510(k) clearance on 2017-08-10. The listed applicant is Telemed. The 510(k) number is K163121.

When did SmartUs EXT-1M/3M receive FDA 510(k) clearance?

SmartUs EXT-1M/3M received FDA 510(k) clearance on 2017-08-10, under 510(k) number K163121.

Who is the listed applicant for SmartUs EXT-1M/3M?

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

What is the FDA product code for SmartUs EXT-1M/3M?

The FDA product code for SmartUs EXT-1M/3M is IYN.

其他以 Telemed 為申請人之記錄

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K211248ArtUs K161968微瑞斯

相關器械（代碼：IYN）

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。

官方來源

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