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FDA 510(k)

全視野AI生命徵象

K 號:K240890 · 2024-12-23

決定日期2024-12-23
產品代碼QME
諮詢委員會履歷
決定相當於

器材摘要

PanopticAI Vital Signs is the device name listed in this FDA 510(k) record. The listed applicant is PanopticAI technologies Limited. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K240890. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PanopticAI Vital Signs?

PanopticAI Vital Signs is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is PanopticAI technologies Limited. The 510(k) number is K240890.

When did PanopticAI Vital Signs receive FDA 510(k) clearance?

PanopticAI Vital Signs received FDA 510(k) clearance on 2024-12-23, under 510(k) number K240890.

Who is the listed applicant for PanopticAI Vital Signs?

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

What is the FDA product code for PanopticAI Vital Signs?

The FDA product code for PanopticAI Vital Signs is QME.

相關臨床試驗

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其他以 PanopticAI technologies Limited 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。

相關器械(代碼:QME)

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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