FDA 510(k)

Hailie Sensor

K号: K182638 · 2019-06-19

决定日期2019-06-19

产品代码CAF

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决定实质等同

器械摘要

Hailie Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Adherium (Nz), Ltd.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K182638. 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 Hailie Sensor?

Hailie Sensor is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Adherium (Nz), Ltd.. The 510(k) number is K182638.

When did Hailie Sensor receive FDA 510(k) clearance?

Hailie Sensor received FDA 510(k) clearance on 2019-06-19, under 510(k) number K182638.

Who is the listed applicant for Hailie Sensor?

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

What is the FDA product code for Hailie Sensor?

The FDA product code for Hailie Sensor is CAF.

列明Adherium (Nz), 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。

K222247Hailie Sensor NF0110 K221994Hailie Sensor NF0107 & NF0108 K220622Hailie Sensor NF0106 K211233Hailie Sensor NF0109 K182573Hailie Sensor K181405Hailie Sensor

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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.

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