FDA 510(k)

AirSpiral加热呼吸管

K号: K162553 · 2018-12-20

决定日期2018-12-20

产品代码BTT

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决定实质等同

器械摘要

AirSpiral Heated Breathing Tube is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K162553. 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 AirSpiral Heated Breathing Tube?

AirSpiral Heated Breathing Tube is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is Fisher & Paykel Healthcare. The 510(k) number is K162553.

When did AirSpiral Heated Breathing Tube receive FDA 510(k) clearance?

AirSpiral Heated Breathing Tube received FDA 510(k) clearance on 2018-12-20, under 510(k) number K162553.

Who is the listed applicant for AirSpiral Heated Breathing Tube?

The FDA 510(k) record lists Fisher & Paykel Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirSpiral Heated Breathing Tube?

The FDA product code for AirSpiral Heated Breathing Tube is BTT.

列明Fisher & Paykel Healthcare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。

K222292F&P myAirvo 3 K220703F&P 950呼吸加湿器 K221338F&P Airvo 3 K162582HumiGard 手术加湿系统，HumiGard 加湿吹入套件

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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