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FDA 510(k)

虛擬病患

K 號:K180697 · 2018-07-10

申請人Rtsafe, Inc.
決定日期2018-07-10
產品代碼IYE
諮詢委員會RA
決定相當於

器材摘要

Pseudo-Patient is the device name listed in this FDA 510(k) record. The listed applicant is Rtsafe, Inc.. It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K180697. 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 Pseudo-Patient?

Pseudo-Patient is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is Rtsafe, Inc.. The 510(k) number is K180697.

When did Pseudo-Patient receive FDA 510(k) clearance?

Pseudo-Patient received FDA 510(k) clearance on 2018-07-10, under 510(k) number K180697.

Who is the listed applicant for Pseudo-Patient?

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

What is the FDA product code for Pseudo-Patient?

The FDA product code for Pseudo-Patient 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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