RegenesisTM Reprieve
K号: K223620 · 2023-05-24
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决定日期2023-05-24
产品代码IMJ
咨询委员会PM
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决定实质等同
器械摘要
Reprieve by RegenesisTM is the device name listed in this FDA 510(k) record. The listed applicant is Regenesis Biomedical, Inc.. It received FDA 510(k) clearance on 2023-05-24 under 510(k) number K223620. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Reprieve by RegenesisTM?
Reprieve by RegenesisTM is a medical device that received FDA 510(k) clearance on 2023-05-24. The listed applicant is Regenesis Biomedical, Inc.. The 510(k) number is K223620.
When did Reprieve by RegenesisTM receive FDA 510(k) clearance?
Reprieve by RegenesisTM received FDA 510(k) clearance on 2023-05-24, under 510(k) number K223620.
Who is the listed applicant for Reprieve by RegenesisTM?
The FDA 510(k) record lists Regenesis Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Reprieve by RegenesisTM?
The FDA product code for Reprieve by RegenesisTM is IMJ.
相关临床试验
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相关器械（代码：IMJ）
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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