REMEX Xcam6
K号: K250597 · 2025-07-31
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器械摘要
REMEX Xcam6 is the device name listed in this FDA 510(k) record. The listed applicant is Remedi, Inc.. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K250597. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the REMEX Xcam6?
REMEX Xcam6 is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is Remedi, Inc.. The 510(k) number is K250597.
When did REMEX Xcam6 receive FDA 510(k) clearance?
REMEX Xcam6 received FDA 510(k) clearance on 2025-07-31, under 510(k) number K250597.
Who is the listed applicant for REMEX Xcam6?
The FDA 510(k) record lists Remedi, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for REMEX Xcam6?
The FDA product code for REMEX Xcam6 is IZL.
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。
相关器械（代码：IZL）
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。
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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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