ELLAVI UBT
K号: K230849 · 2023-11-13
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决定日期2023-11-13
产品代码OQY
咨询委员会OB
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决定实质等同
器械摘要
ELLAVI UBT is the device name listed in this FDA 510(k) record. The listed applicant is Sinapi Biomedical (Pty) , Ltd.. It received FDA 510(k) clearance on 2023-11-13 under 510(k) number K230849. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ELLAVI UBT?
ELLAVI UBT is a medical device that received FDA 510(k) clearance on 2023-11-13. The listed applicant is Sinapi Biomedical (Pty) , Ltd.. The 510(k) number is K230849.
When did ELLAVI UBT receive FDA 510(k) clearance?
ELLAVI UBT received FDA 510(k) clearance on 2023-11-13, under 510(k) number K230849.
Who is the listed applicant for ELLAVI UBT?
The FDA 510(k) record lists Sinapi Biomedical (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ELLAVI UBT?
The FDA product code for ELLAVI UBT is OQY.
相关临床试验
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相关器械（代码：OQY）
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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