FDA 510(k)

需求鼻氧氣管，改良需求鼻氧氣管

K 號：K151506 · 2016-03-11

決定日期2016-03-11

產品代碼NFB

諮詢委員會AN

決定相當於

器材摘要

Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K151506. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula?

Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Salter Labs. The 510(k) number is K151506.

When did Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula receive FDA 510(k) clearance?

Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula received FDA 510(k) clearance on 2016-03-11, under 510(k) number K151506.

Who is the listed applicant for Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula?

FDA 510(k) 記錄將 Salter Labs 列為申請人。這並不能單獨確立設備製造商。

What is the FDA product code for Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula?

The FDA product code for Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula is NFB.

其他以 Salter Labs 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。

K261389PRO2 Elite Plus 氧氣分析儀 (PRO2PLUS-1)K161719Salter Labs 氣泡濕化器 K151874BiNAPS 鼻腔氣流及鼾聲傳感器；ThermiSense 口腔/鼻腔熱氣流傳感器，配氣流壓力針筒，鼻腔及口腔/鼻腔 K151421鼻部CO2樣品管路，口鼻CO2採樣針管，氧氣口鼻CO2針管，樣品管路

相關器械（代碼：NFB）

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。

K250322應答保護監管設備（130-0800）Responsive Respiratory K220591ProximaDynasthetics, LLC K221014無縫氧氣儲存系統型號Effortless Pro和Effortless MobileEffortless Oxygen, LLC K200401ApogeeIncoba Ltd D/B/A Dynaris

官方來源

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