FDA 510(k)

Model 9160 VitaloQUB

K号: K223818 · 2023-05-25

决定日期2023-05-25

产品代码JEH

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决定实质等同

器械摘要

Model 9160 VitaloQUB is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph Ireland, Ltd.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K223818. The device is classified under product code JEH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Model 9160 VitaloQUB?

Model 9160 VitaloQUB is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Vitalograph Ireland, Ltd.. The 510(k) number is K223818.

When did Model 9160 VitaloQUB receive FDA 510(k) clearance?

Model 9160 VitaloQUB received FDA 510(k) clearance on 2023-05-25, under 510(k) number K223818.

Who is the listed applicant for Model 9160 VitaloQUB?

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

What is the FDA product code for Model 9160 VitaloQUB?

The FDA product code for Model 9160 VitaloQUB is JEH.

列明Vitalograph Ireland, 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。

K221030型号9100肺功能/呼吸流量计 K212938Vitalograph型号6000 Alpha K201562Spirotrac K200550Vitalograph型号2120 In2itive电子日记 K160253Vitalograph型号6300微型

官方来源

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