FDA 510(k)

eRapid雾化器系统

K号: K223840 · 2023-08-11

决定日期2023-08-11

产品代码CAF

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决定实质等同

器械摘要

eRapid Nebulizer System is the device name listed in this FDA 510(k) record. The listed applicant is Pari Respiratory Equipment, Inc.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K223840. 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 eRapid Nebulizer System?

eRapid Nebulizer System is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Pari Respiratory Equipment, Inc.. The 510(k) number is K223840.

When did eRapid Nebulizer System receive FDA 510(k) clearance?

eRapid Nebulizer System received FDA 510(k) clearance on 2023-08-11, under 510(k) number K223840.

Who is the listed applicant for eRapid Nebulizer System?

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

What is the FDA product code for eRapid Nebulizer System?

The FDA product code for eRapid Nebulizer System is CAF.

列明Pari Respiratory Equipment, 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。

K251572eRapid带eTrack系统 K191270Proneb Max K162785速捷雾化器系统 K150044O-PEP

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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