FDA 510(k)

Airvo 超声雾化器适配器

K号: K211560 · 2021-12-10

决定日期2021-12-10

产品代码CAF

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决定实质等同

器械摘要

Airvo Nebulizer Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K211560. 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 Airvo Nebulizer Adapter?

Airvo Nebulizer Adapter is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Fisher & Paykel Healthcare Limited. The 510(k) number is K211560.

When did Airvo Nebulizer Adapter receive FDA 510(k) clearance?

Airvo Nebulizer Adapter received FDA 510(k) clearance on 2021-12-10, under 510(k) number K211560.

Who is the listed applicant for Airvo Nebulizer Adapter?

The FDA 510(k) record lists Fisher & Paykel Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Airvo Nebulizer Adapter?

The FDA product code for Airvo Nebulizer Adapter is CAF.

列明Fisher & Paykel Healthcare Limited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。

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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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