FDA 510(k)

Vitalograph型号6000 Alpha

K号: K212938 · 2022-01-26

决定日期2022-01-26

产品代码BZG

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决定实质等同

器械摘要

Vitalograph Model 6000 Alpha 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 2022-01-26 under 510(k) number K212938. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vitalograph Model 6000 Alpha?

Vitalograph Model 6000 Alpha is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Vitalograph Ireland, Ltd.. The 510(k) number is K212938.

When did Vitalograph Model 6000 Alpha receive FDA 510(k) clearance?

Vitalograph Model 6000 Alpha received FDA 510(k) clearance on 2022-01-26, under 510(k) number K212938.

Who is the listed applicant for Vitalograph Model 6000 Alpha?

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 Vitalograph Model 6000 Alpha?

The FDA product code for Vitalograph Model 6000 Alpha is BZG.

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。

K223818Model 9160 VitaloQUB K221030型号9100肺功能/呼吸流量计 K201562Spirotrac K200550Vitalograph型号2120 In2itive电子日记 K160253Vitalograph型号6300微型

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