AirLife Misty Finity 喷雾器
K号: K153748 · 2017-05-17
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申请人Care Fusion
决定日期2017-05-17
产品代码CAF
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
AirLife Misty Finity Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2017-05-17 under 510(k) number K153748. 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 AirLife Misty Finity Nebulizer?
AirLife Misty Finity Nebulizer is a medical device that received FDA 510(k) clearance on 2017-05-17. The listed applicant is Care Fusion. The 510(k) number is K153748.
When did AirLife Misty Finity Nebulizer receive FDA 510(k) clearance?
AirLife Misty Finity Nebulizer received FDA 510(k) clearance on 2017-05-17, under 510(k) number K153748.
Who is the listed applicant for AirLife Misty Finity Nebulizer?
The FDA 510(k) record lists Care Fusion as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AirLife Misty Finity Nebulizer?
The FDA product code for AirLife Misty Finity 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Care Fusion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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