FDA 510(k)

AdheResp Smart Breath-actuated Mesh Nebulizer

K号: K250583 · 2025-06-20

决定日期2025-06-20

产品代码CAF

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决定实质等同

器械摘要

AdheResp Smart Breath-actuated Mesh Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Hcmed Innovations Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K250583. 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 AdheResp Smart Breath-actuated Mesh Nebulizer?

AdheResp Smart Breath-actuated Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Hcmed Innovations Co., Ltd.. The 510(k) number is K250583.

When did AdheResp Smart Breath-actuated Mesh Nebulizer receive FDA 510(k) clearance?

AdheResp Smart Breath-actuated Mesh Nebulizer received FDA 510(k) clearance on 2025-06-20, under 510(k) number K250583.

Who is the listed applicant for AdheResp Smart Breath-actuated Mesh Nebulizer?

The FDA 510(k) record lists Hcmed Innovations Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AdheResp Smart Breath-actuated Mesh Nebulizer?

The FDA product code for AdheResp Smart Breath-actuated Mesh Nebulizer is CAF.

列明Hcmed Innovations 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。

K202171Pulmogine 振动网状雾化器

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.

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