FDA 510(k)

量子診斷模組，量子診斷模組 - 不含氣體

K 號：K173591 · 2018-03-28

決定日期2018-03-28

產品代碼DRY

諮詢委員會履歷

決定相當於

器材摘要

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas 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 2018-03-28 under 510(k) number K173591. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas?

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K173591.

When did Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas receive FDA 510(k) clearance?

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas received FDA 510(k) clearance on 2018-03-28, under 510(k) number K173591.

Who is the listed applicant for Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas?

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 Diagnostic Module, Quantum Diagnostic Module - No Gas?

The FDA product code for Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas is DRY.

其他以 Spectrum Medical , Ltd. 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。

K240908量子微心臟停跳輸送系統；量子微心臟停跳輸送模組（QMCDM）K212657量子加熱冷卻設備 K210669量子迷你通氣模組 K202733量子通氣模組 K202557量子工作站 12 精英 K192838量子離心驅動-高壓，量子離心驅動-中壓

查看所有 12 項裝置 →

相關器械（代碼：DRY）

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。

K234065CDI OneView 監控系統Terumo Cardiovascular Systems Corporation K202154B-CaptaLivanova Deutschland, GmbH K202557量子工作站 12 精英Spectrum Medical , Ltd.K182110CDI 血液參數監測系統 550Terumo Cardiovascular Systems Corporation K181923量子工作站 12.1Spectrum Medical , Ltd.K163657量子工作站Spectrum Medical , Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。