FindAir ONE 用于 pMDI (FAO-MDI-V12-GRE-001)
K号: K260270 · 2026-06-02
广告
决定日期2026-06-02
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
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) is the device name listed in this FDA 510(k) record. The listed applicant is FindAir Sp. z o.o.. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K260270. 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 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)?
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is FindAir Sp. z o.o.. The 510(k) number is K260270.
When did FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) receive FDA 510(k) clearance?
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) received FDA 510(k) clearance on 2026-06-02, under 510(k) number K260270.
Who is the listed applicant for FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)?
The FDA 510(k) record lists FindAir Sp. z o.o. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)?
The FDA product code for FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) 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。
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.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.K250022HeroTracker SenseVoluntis
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。
广告