FDA 510(k)

IntraSight 移动版

K号: K203719 · 2021-01-19

决定日期2021-01-19

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

IntraSight Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2021-01-19 under 510(k) number K203719. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IntraSight Mobile?

IntraSight Mobile is a medical device that received FDA 510(k) clearance on 2021-01-19. The listed applicant is Volcano Corporation. The 510(k) number is K203719.

When did IntraSight Mobile receive FDA 510(k) clearance?

IntraSight Mobile received FDA 510(k) clearance on 2021-01-19, under 510(k) number K203719.

Who is the listed applicant for IntraSight Mobile?

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

What is the FDA product code for IntraSight Mobile?

The FDA product code for IntraSight Mobile is IYO.

列明Volcano Corporation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。

K210235Verrata PLUS 压力导丝 K202543OmniWire 压力导丝，185 cm 直头，OmniWire 压力导丝，185 cm J型头 K192886OmniWire 压力导丝，185 cm 直头，OmniWire 压力导丝，185 cm J型头 K190626SyncVision System K190078IntraSight K173860s5 血管内超声成像和压力系统，s5i 血管内超声成像和压力系统，CORE 精准引导治疗系统，CORE 移动精准引导治疗系统

查看所有 13 个设备 →

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。