HOMED 网状雾化器
K号: K170886 · 2018-06-21
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决定日期2018-06-21
产品代码CAF
咨询委员会AN
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决定实质等同
器械摘要
HOMED Mesh Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Homed Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2018-06-21 under 510(k) number K170886. 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 HOMED Mesh Nebulizer?
HOMED Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2018-06-21. The listed applicant is Shenzhen Homed Medical Device Co., Ltd.. The 510(k) number is K170886.
When did HOMED Mesh Nebulizer receive FDA 510(k) clearance?
HOMED Mesh Nebulizer received FDA 510(k) clearance on 2018-06-21, under 510(k) number K170886.
Who is the listed applicant for HOMED Mesh Nebulizer?
The FDA 510(k) record lists Shenzhen Homed Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HOMED Mesh Nebulizer?
The FDA product code for HOMED Mesh Nebulizer is CAF.
相关临床试验
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。
列明Shenzhen Homed Medical Device 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。
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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