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FDA 510(k)

Dosimetry Check 版本5版次1

K 號:K162577 · 2016-11-18

決定日期2016-11-18
產品代碼IYE
諮詢委員會RA
決定相當於

器材摘要

Dosimetry Check Version 5 Release 1 is the device name listed in this FDA 510(k) record. The listed applicant is Math Resolutions, LLC. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K162577. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dosimetry Check Version 5 Release 1?

Dosimetry Check Version 5 Release 1 is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Math Resolutions, LLC. The 510(k) number is K162577.

When did Dosimetry Check Version 5 Release 1 receive FDA 510(k) clearance?

Dosimetry Check Version 5 Release 1 received FDA 510(k) clearance on 2016-11-18, under 510(k) number K162577.

Who is the listed applicant for Dosimetry Check Version 5 Release 1?

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

What is the FDA product code for Dosimetry Check Version 5 Release 1?

The FDA product code for Dosimetry Check Version 5 Release 1 is IYE.

相關臨床試驗

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相關器械(代碼:IYE)

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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