FDA 510(k)

通用飞行员引导仪器系统

K号: K213491 · 2022-05-12

决定日期2022-05-12

产品代码OLO

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Universal Pilot Guidance Instrument System is the device name listed in this FDA 510(k) record. The listed applicant is Ctl Medical Corporation. It received FDA 510(k) clearance on 2022-05-12 under 510(k) number K213491. 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 Universal Pilot Guidance Instrument System?

Universal Pilot Guidance Instrument System is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Ctl Medical Corporation. The 510(k) number is K213491.

When did Universal Pilot Guidance Instrument System receive FDA 510(k) clearance?

Universal Pilot Guidance Instrument System received FDA 510(k) clearance on 2022-05-12, under 510(k) number K213491.

Who is the listed applicant for Universal Pilot Guidance Instrument System?

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

What is the FDA product code for Universal Pilot Guidance Instrument System?

The FDA product code for Universal Pilot Guidance Instrument System is OLO.

列明Ctl Medical 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。

K233947KLIMT™ 可扩张腰椎椎间融合（LIF）笼系统 K231715MONDRIAN™ 腰椎前柱板系统 K231359RODIN®可扩张腰椎笼系统 K220513NITRO Interbody Fusion Cage System Family K220334MONET 前颈椎板系统 K211785CASSATT™ SIJ 固定系统

查看所有 14 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。