FDA 510(k)

Hamilton-G5

K号: K193228 · 2020-05-04

决定日期2020-05-04

产品代码CBK

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Hamilton-G5 is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Medical AG. It received FDA 510(k) clearance on 2020-05-04 under 510(k) number K193228. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hamilton-G5?

Hamilton-G5 is a medical device that received FDA 510(k) clearance on 2020-05-04. The listed applicant is Hamilton Medical AG. The 510(k) number is K193228.

When did Hamilton-G5 receive FDA 510(k) clearance?

Hamilton-G5 received FDA 510(k) clearance on 2020-05-04, under 510(k) number K193228.

Who is the listed applicant for Hamilton-G5?

The FDA 510(k) record lists Hamilton Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hamilton-G5?

The FDA product code for Hamilton-G5 is CBK.

列明Hamilton Medical AG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。

K201306HAMILTON-C3 K201658Hamilton-C6 K181216HAMILTON-T1，HAMILTON-C1 K163283HAMILTON-H900，HAMILTON-BC8010，HAMILTON-BC4010 K161450HAMILTON-C3 K153046HAMILTON-MR1

查看所有 9 个设备 →

相关器械（代码：CBK）

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。

K253647Evita（V800）；Evita（V600）Draegerwerk AG & CO Kgaa K252663Inbentus多用途Iconic Solutions by Murcia, SL K251888VPAP儿童面罩Hsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸A (ONIV117A)；F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸B (ONIV117B)；F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸C (ONIV117C)；F&P OptiNIV ONIV117-F医院通气全脸面罩带可选呼气过滤器与单肢电路兼容 - 尺寸A (ONIV117A-F)；F&P OptiNIV ONIV117-F医院通气全脸面罩Fisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。