IsoSphere
K号: K242818 · 2025-07-15
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器械摘要
IsoSphere is the device name listed in this FDA 510(k) record. The listed applicant is Isoaid, LLC. It received FDA 510(k) clearance on 2025-07-15 under 510(k) number K242818. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the IsoSphere?
IsoSphere is a medical device that received FDA 510(k) clearance on 2025-07-15. The listed applicant is Isoaid, LLC. The 510(k) number is K242818.
When did IsoSphere receive FDA 510(k) clearance?
IsoSphere received FDA 510(k) clearance on 2025-07-15, under 510(k) number K242818.
Who is the listed applicant for IsoSphere?
The FDA 510(k) record lists Isoaid, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IsoSphere?
The FDA product code for IsoSphere is KXK.
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相关器械（代码：KXK）
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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