FDA 510(k)

SenSmart 模型8006CA 可重用局部血氧濃度感測器，SenSmart 模型8006PI 一次性病人介面

K 號：K190560 · 2019-05-02

決定日期2019-05-02

產品代碼MUD

諮詢委員會履歷

決定相當於

器材摘要

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface is the device name listed in this FDA 510(k) record. The listed applicant is Nonin Medical, Inc.. It received FDA 510(k) clearance on 2019-05-02 under 510(k) number K190560. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface?

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface is a medical device that received FDA 510(k) clearance on 2019-05-02. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K190560.

When did SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface receive FDA 510(k) clearance?

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface received FDA 510(k) clearance on 2019-05-02, under 510(k) number K190560.

Who is the listed applicant for SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface?

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

What is the FDA product code for SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface?

The FDA product code for SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface is MUD.

其他以 Nonin Medical, Inc. 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。

K211498非侵入式OTC血氧濃度計模型3250 K192900H500 多感知血氧測量系統 K191403心電血氧濃度計 K172625可重用式，指尖針非侵入性醫用CO-血氧濃度測量感應器 K160231X-100C CO-Met™ 血氧儀系統 K1608656100C系列單一病人使用、一次性脉搏血氧儀感測器（6100C系列：6100CA、6100CP、6100CI、6100CN），6101C系列單一病人使用、一次性脉搏血氧儀感測器（6101C系列：6101CA、6101CP、6101CI、6101CN），6102C系列單一病人使用、一次性脉搏血氧儀感測器（6102C系列：6102CA、6102CP、6102CI、6102CN），8100AA/8100AP可重用、手指夾式脉搏血氧儀感測器，8101AA/8101AP可重用、手指夾式脉搏血氧儀感測器

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相關器械（代碼：MUD）

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。

K254129Spectrum-2Neko Health AB K243324馬斯米O3地區性血氧儀Masimo Corporation K250519Lap.Ox™ 鍋鏡組織氧濃度計ViOptix, Inc.K240596大腦自調節指數（CAI）算法Edwards Lifesciences K241393ODI-TechOdi Medical AS K240601快照NIR型 KD205Kent Imaging, Inc.

官方來源

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