免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Panther Stereotactic

K号: K193459 · 2020-04-27

申请人Prowess, Inc.
决定日期2020-04-27
产品代码MUJ
咨询委员会RA
决定实质等同

器械摘要

Panther Stereotactic is the device name listed in this FDA 510(k) record. The listed applicant is Prowess, Inc.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K193459. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Panther Stereotactic?

Panther Stereotactic is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Prowess, Inc.. The 510(k) number is K193459.

When did Panther Stereotactic receive FDA 510(k) clearance?

Panther Stereotactic received FDA 510(k) clearance on 2020-04-27, under 510(k) number K193459.

Who is the listed applicant for Panther Stereotactic?

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

What is the FDA product code for Panther Stereotactic?

The FDA product code for Panther Stereotactic is MUJ.

相关临床试验

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。

列明Prowess, 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。

相关器械(代码:MUJ)

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。

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。

↑