Mendaera 导航系统
K号: K250524 · 2025-07-02
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器械摘要
Mendaera Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is Mendaera, Inc.. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250524. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Mendaera Guidance System?
Mendaera Guidance System is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Mendaera, Inc.. The 510(k) number is K250524.
When did Mendaera Guidance System receive FDA 510(k) clearance?
Mendaera Guidance System received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250524.
Who is the listed applicant for Mendaera Guidance System?
The FDA 510(k) record lists Mendaera, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mendaera Guidance System?
The FDA product code for Mendaera Guidance System is ITX.
相关临床试验
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相关器械（代码：ITX）
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。
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