FDA 510(k)

便携式雾化器

K号: K170916 · 2017-11-28

决定日期2017-11-28

产品代码CAF

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决定实质等同

器械摘要

Portable Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Microbase Technology Corporation. It received FDA 510(k) clearance on 2017-11-28 under 510(k) number K170916. 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 Portable Nebulizer?

Portable Nebulizer is a medical device that received FDA 510(k) clearance on 2017-11-28. The listed applicant is Microbase Technology Corporation. The 510(k) number is K170916.

When did Portable Nebulizer receive FDA 510(k) clearance?

Portable Nebulizer received FDA 510(k) clearance on 2017-11-28, under 510(k) number K170916.

Who is the listed applicant for Portable Nebulizer?

The FDA 510(k) record lists Microbase Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Nebulizer?

The FDA product code for Portable Nebulizer is CAF.

列明Microbase Technology Corporation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。

K180871便携式雾化器

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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