Fenom Pro
K号: K213611 · 2023-06-07
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决定日期2023-06-07
产品代码MXA
咨询委员会TX
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决定实质等同
器械摘要
Fenom Pro is the device name listed in this FDA 510(k) record. The listed applicant is Caire Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-06-07 under 510(k) number K213611. The device is classified under product code MXA. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Fenom Pro?
Fenom Pro is a medical device that received FDA 510(k) clearance on 2023-06-07. The listed applicant is Caire Diagnostics, Inc.. The 510(k) number is K213611.
When did Fenom Pro receive FDA 510(k) clearance?
Fenom Pro received FDA 510(k) clearance on 2023-06-07, under 510(k) number K213611.
Who is the listed applicant for Fenom Pro?
The FDA 510(k) record lists Caire Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fenom Pro?
The FDA product code for Fenom Pro is MXA.
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相关器械（代码：MXA）
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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