FDA 510(k)

便携式网状雾化器

K号: K182906 · 2020-09-27

决定日期2020-09-27

产品代码CAF

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决定实质等同

器械摘要

Portable Mesh Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Feellife Health, Inc.. It received FDA 510(k) clearance on 2020-09-27 under 510(k) number K182906. 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 Mesh Nebulizer?

Portable Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2020-09-27. The listed applicant is Feellife Health, Inc.. The 510(k) number is K182906.

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

Portable Mesh Nebulizer received FDA 510(k) clearance on 2020-09-27, under 510(k) number K182906.

Who is the listed applicant for Portable Mesh Nebulizer?

The FDA 510(k) record lists Feellife Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Mesh Nebulizer?

The FDA product code for Portable Mesh Nebulizer is CAF.

列明Feellife Health, Inc.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。

K222443空气压缩腿部按摩器（MM0520，MM0521，MM0522）

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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