FDA 510(k)

INTAI 手术导航系统

K号: K180523 · 2019-09-20

决定日期2019-09-20

产品代码OLO

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决定实质等同

器械摘要

INTAI Surgery Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Intai Technology Corporation. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K180523. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the INTAI Surgery Navigation System?

INTAI Surgery Navigation System is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Intai Technology Corporation. The 510(k) number is K180523.

When did INTAI Surgery Navigation System receive FDA 510(k) clearance?

INTAI Surgery Navigation System received FDA 510(k) clearance on 2019-09-20, under 510(k) number K180523.

Who is the listed applicant for INTAI Surgery Navigation System?

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

What is the FDA product code for INTAI Surgery Navigation System?

The FDA product code for INTAI Surgery Navigation System is OLO.

列明Intai Technology 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。

K201229Intai 解剖锁定板和螺钉系统

官方来源

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