FDA 510(k)

微瑞斯

K 號：K161968 · 2016-11-03

決定日期2016-11-03

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

MicrUs is the device name listed in this FDA 510(k) record. The listed applicant is Telemed. It received FDA 510(k) clearance on 2016-11-03 under 510(k) number K161968. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MicrUs?

MicrUs is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Telemed. The 510(k) number is K161968.

When did MicrUs receive FDA 510(k) clearance?

MicrUs received FDA 510(k) clearance on 2016-11-03, under 510(k) number K161968.

Who is the listed applicant for MicrUs?

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 MicrUs?

The FDA product code for MicrUs is IYO.

其他以 Telemed 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。

K211248ArtUs K163121SmartUs EXT-1M/3M

相關器械（代碼：IYO）

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。

K260313MD-6000S 膀胱掃描儀MEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT 扫描儀 2000 型號 AQT Imaging Holdings, Inc.

官方來源

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