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FDA 510(k)

根據健康攝影機(G1.D5)

K 號:K230996 · 2024-01-04

決定日期2024-01-04
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Pursuant Health Kiosk (G1.D5) is the device name listed in this FDA 510(k) record. The listed applicant is Pursuant Health. It received FDA 510(k) clearance on 2024-01-04 under 510(k) number K230996. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pursuant Health Kiosk (G1.D5)?

Pursuant Health Kiosk (G1.D5) is a medical device that received FDA 510(k) clearance on 2024-01-04. The listed applicant is Pursuant Health. The 510(k) number is K230996.

When did Pursuant Health Kiosk (G1.D5) receive FDA 510(k) clearance?

Pursuant Health Kiosk (G1.D5) received FDA 510(k) clearance on 2024-01-04, under 510(k) number K230996.

Who is the listed applicant for Pursuant Health Kiosk (G1.D5)?

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

What is the FDA product code for Pursuant Health Kiosk (G1.D5)?

The FDA product code for Pursuant Health Kiosk (G1.D5) is DXN.

相關臨床試驗

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。

相關器械(代碼:DXN)

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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