免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Girgis 视频显微镜 200 双刃喉镜 (GSV200.DBL)

K号: K163412 · 2017-06-22

决定日期2017-06-22
产品代码CCW
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

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is the device name listed in this FDA 510(k) record. The listed applicant is Girgis Scope, LLC. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K163412. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)?

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Girgis Scope, LLC. The 510(k) number is K163412.

When did Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) receive FDA 510(k) clearance?

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) received FDA 510(k) clearance on 2017-06-22, under 510(k) number K163412.

Who is the listed applicant for Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)?

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

What is the FDA product code for Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)?

The FDA product code for Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is CCW.

相关临床试验

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。

相关器械(代码:CCW)

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。

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。

↑