FDA 510(k)

量子通氣模組

K 號：K181942 · 2018-10-18

決定日期2018-10-18

產品代碼DTX

諮詢委員會履歷

決定相當於

器材摘要

Quantum Ventilation Module is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2018-10-18 under 510(k) number K181942. The device is classified under product code DTX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantum Ventilation Module?

Quantum Ventilation Module is a medical device that received FDA 510(k) clearance on 2018-10-18. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K181942.

When did Quantum Ventilation Module receive FDA 510(k) clearance?

Quantum Ventilation Module received FDA 510(k) clearance on 2018-10-18, under 510(k) number K181942.

Who is the listed applicant for Quantum Ventilation Module?

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

What is the FDA product code for Quantum Ventilation Module?

The FDA product code for Quantum Ventilation Module is DTX.

其他以 Spectrum Medical , Ltd. 為申請人之記錄

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相關器械（代碼：DTX）

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。

K210669量子迷你通氣模組Spectrum Medical , Ltd.K202733量子通氣模組Spectrum Medical , Ltd.

官方來源

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