FDA 510(k)

StealthStation System with Cranial Software

K号: K153660 · 2016-09-14

决定日期2016-09-14

产品代码HAW

咨询委员会NE

决定Substantially Equivalent

器械摘要

StealthStation System with Cranial Software is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K153660. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the StealthStation System with Cranial Software?

StealthStation System with Cranial Software is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K153660.

When did StealthStation System with Cranial Software receive FDA 510(k) clearance?

StealthStation System with Cranial Software received FDA 510(k) clearance on 2016-09-14, under 510(k) number K153660.

Who is the listed applicant for StealthStation System with Cranial Software?

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

What is the FDA product code for StealthStation System with Cranial Software?

The FDA product code for StealthStation System with Cranial Software is HAW.

列明Medtronic Navigation, Inc.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。

K253379Stealth AXiS Cranial clinical application K253395Stealth AXiS™ ENT clinical application K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application K251282StealthStation S8 Spine Software K242464Stealth™ Spine Clamps; ModuLeX™ Shank Mounts

查看所有 24 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。