FDA 510(k)

MADgic 喉气管黏膜气溶胶化装置

K号: K153470 · 2016-08-19

决定日期2016-08-19

产品代码CCT

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

MADgic Laryngo-Tracheal Mucosal Atomization Device is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2016-08-19 under 510(k) number K153470. The device is classified under product code CCT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MADgic Laryngo-Tracheal Mucosal Atomization Device?

MADgic Laryngo-Tracheal Mucosal Atomization Device is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Teleflex Medical. The 510(k) number is K153470.

When did MADgic Laryngo-Tracheal Mucosal Atomization Device receive FDA 510(k) clearance?

MADgic Laryngo-Tracheal Mucosal Atomization Device received FDA 510(k) clearance on 2016-08-19, under 510(k) number K153470.

Who is the listed applicant for MADgic Laryngo-Tracheal Mucosal Atomization Device?

FDA 510(k)记录显示Teleflex Medical为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for MADgic Laryngo-Tracheal Mucosal Atomization Device?

The FDA product code for MADgic Laryngo-Tracheal Mucosal Atomization Device is CCT.

列明Teleflex Medical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。

K261418Liquick X-treme，Liquick X-treme Plus K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips K242495LMA Fastrach ETT SU K243553QuikClot Control+ 止血装置 K241784Arrow® Nitinol Wire K233713Pilling 气管切开管

查看所有 21 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。