FDA 510(k)

Salter Labs 氣泡濕化器

K 號：K161719 · 2017-09-21

決定日期2017-09-21

產品代碼BTT

諮詢委員會AN

決定相當於

器材摘要

Salter Labs Bubble Humidifier is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 2017-09-21 under 510(k) number K161719. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Salter Labs Bubble Humidifier?

Salter Labs Bubble Humidifier is a medical device that received FDA 510(k) clearance on 2017-09-21. The listed applicant is Salter Labs. The 510(k) number is K161719.

When did Salter Labs Bubble Humidifier receive FDA 510(k) clearance?

Salter Labs Bubble Humidifier received FDA 510(k) clearance on 2017-09-21, under 510(k) number K161719.

Who is the listed applicant for Salter Labs Bubble Humidifier?

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 Salter Labs Bubble Humidifier?

The FDA product code for Salter Labs Bubble Humidifier is BTT.

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)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 K151506需求鼻氧氣管，改良需求鼻氧氣管 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：BTT）

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。

K262268Optiflow 氧氣套件 (AA484J)Fisher and Paykel Healthcare Limited K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U 呼吸濕化器Flexicare Medical Limited.K251419生物加倫尼克實驗室靜脈注射用无菌水，USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ 過濾鼻接口配二氧化碳採樣功能 (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® 舒適流鼻管預產期、嬰兒；Hudson RCI® 舒適流 Plus 及軟 Plus 鼻管超小號Medline Industries, LP

官方來源

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