FDA 510(k)

StealthStation颅骨软件v1.3.0

K号: K201175 · 2020-06-03

决定日期2020-06-03

产品代码HAW

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决定实质等同

器械摘要

StealthStation Cranial Software v1.3.0 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 2020-06-03 under 510(k) number K201175. 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 Cranial Software v1.3.0?

StealthStation Cranial Software v1.3.0 is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K201175.

When did StealthStation Cranial Software v1.3.0 receive FDA 510(k) clearance?

StealthStation Cranial Software v1.3.0 received FDA 510(k) clearance on 2020-06-03, under 510(k) number K201175.

Who is the listed applicant for StealthStation Cranial Software v1.3.0?

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 Cranial Software v1.3.0?

The FDA product code for StealthStation Cranial Software v1.3.0 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颅部临床应用 K253395Stealth AXiS™ ENT临床应用 K253391Visualase 冷却激光治疗仪系统（9735559）；Visualase 冷却激光治疗仪系统（9735560）；Visualase 冷却激光治疗仪系统（9735561）K253381Stealth AXiS™手术系统及Stealth AXiS™脊柱临床应用 K251282StealthStation S8脊柱软件 K242464Stealth® 脊柱夹具；ModuLeX® 股轴安装座

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官方来源

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