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)

CURVE激光系统

K号: K170709 · 2017-06-06

决定日期2017-06-06
产品代码OLI
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

CURVE Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Yolo Medical, Inc.. It received FDA 510(k) clearance on 2017-06-06 under 510(k) number K170709. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CURVE Laser System?

CURVE Laser System is a medical device that received FDA 510(k) clearance on 2017-06-06. The listed applicant is Yolo Medical, Inc.. The 510(k) number is K170709.

When did CURVE Laser System receive FDA 510(k) clearance?

CURVE Laser System received FDA 510(k) clearance on 2017-06-06, under 510(k) number K170709.

Who is the listed applicant for CURVE Laser System?

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

What is the FDA product code for CURVE Laser System?

The FDA product code for CURVE Laser System is OLI.

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:OLI)

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。

↑