Midas 恢复系统
K号: K260661 · 2026-04-15
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决定日期2026-04-15
产品代码EBF
咨询委员会DE
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决定实质等同
器械摘要
Midas Restore is the device name listed in this FDA 510(k) record. The listed applicant is Sprintray, Inc.. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K260661. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Midas Restore?
Midas Restore is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Sprintray, Inc.. The 510(k) number is K260661.
When did Midas Restore receive FDA 510(k) clearance?
Midas Restore received FDA 510(k) clearance on 2026-04-15, under 510(k) number K260661.
Who is the listed applicant for Midas Restore?
The FDA 510(k) record lists Sprintray, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Midas Restore?
The FDA product code for Midas Restore is EBF.
相关临床试验
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列明Sprintray, 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：EBF）
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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