FDA 510(k)

Salter Labs泡沫加湿器

K号: K161719 · 2017-09-21

决定日期2017-09-21

产品代码BTT

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决定实质等同

器械摘要

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.

常见问题

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) 记录中列出的申请人 Salter Labs 并不本身确立该设备制造商。

What is the FDA product code for Salter Labs Bubble Humidifier?

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

列明Salter Labs为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261389PRO2 Elite Plus 氧气分析仪（PRO2PLUS-1）K151874BiNAPS 鼻腔气流和打鼾传感器；ThermiSense 口腔/鼻腔热空气流传感器带气流压力导管，鼻腔和口腔/鼻腔 K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula K151421鼻CO2采样管，口腔鼻CO2采样管，O2口腔/鼻CO2管，采样管

相关器械（代码：BTT）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262268Optiflow 氧气套件（AA484J）Fisher and Paykel Healthcare Limited K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U 呼吸道加湿器Flexicare Medical Limited.K251419Biogalenic 生物实验室无菌吸入用水，USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ 过滤鼻接口带CO2采样（AA042J）Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo 鼻导管早产儿，婴儿；Hudson RCI® Comfort Flo Plus 和 Soft Plus 鼻导管超小号Medline Industries, LP

官方来源

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