FDA 510(k)

AlertWatch:OB

K号: K173715 · 2018-04-23

决定日期2018-04-23

产品代码HGM

咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

AlertWatch:OB is the device name listed in this FDA 510(k) record. The listed applicant is Alertwatch, Inc.. It received FDA 510(k) clearance on 2018-04-23 under 510(k) number K173715. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AlertWatch:OB?

AlertWatch:OB is a medical device that received FDA 510(k) clearance on 2018-04-23. The listed applicant is Alertwatch, Inc.. The 510(k) number is K173715.

When did AlertWatch:OB receive FDA 510(k) clearance?

AlertWatch:OB received FDA 510(k) clearance on 2018-04-23, under 510(k) number K173715.

Who is the listed applicant for AlertWatch:OB?

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

What is the FDA product code for AlertWatch:OB?

The FDA product code for AlertWatch:OB is HGM.

列明Alertwatch, 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。

K210160AlertWatch：AC

官方来源

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