FDA 510(k)

智能网状雾化器

K号: K171549 · 2018-08-31

申请人Qingdao Future Medical Technology Co., Ltd.

决定日期2018-08-31

产品代码CAF

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决定实质等同

器械摘要

Intelligent Mesh Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Future Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K171549. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Intelligent Mesh Nebulizer?

Intelligent Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Qingdao Future Medical Technology Co., Ltd.. The 510(k) number is K171549.

When did Intelligent Mesh Nebulizer receive FDA 510(k) clearance?

Intelligent Mesh Nebulizer received FDA 510(k) clearance on 2018-08-31, under 510(k) number K171549.

Who is the listed applicant for Intelligent Mesh Nebulizer?

The FDA 510(k) record lists Qingdao Future Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intelligent Mesh Nebulizer?

The FDA product code for Intelligent Mesh Nebulizer is CAF.

列明Qingdao Future Medical Technology Co., Ltd.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。

K251659Mesh Nebulizer (H6)

相关器械（代码：CAF）

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。

K254171网状雾化器（UN204）；网状雾化器（UN205）；网状雾化器（UN209）；网状雾化器（UN210）Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE 用于 pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid带eTrack系统Pari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035便携式网状雾化器（JM821）Shenzhen Jermei Medical Device Technology Co., Ltd.K243468压缩机雾化器（NB-1100）；压缩机雾化器（NB-1101）；压缩机雾化器（NB-1102）；压缩机雾化器（NB-1103）Joytech Healthcare Co. , Ltd.

官方来源

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