HP-OCT (HP-OCT)
K号: K231760 · 2024-03-08
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决定日期2024-03-08
产品代码HJO
咨询委员会OP
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决定实质等同
器械摘要
HP-OCT (HP-OCT) is the device name listed in this FDA 510(k) record. The listed applicant is Cylite Pty. , Ltd.. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K231760. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HP-OCT (HP-OCT)?
HP-OCT (HP-OCT) is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Cylite Pty. , Ltd.. The 510(k) number is K231760.
When did HP-OCT (HP-OCT) receive FDA 510(k) clearance?
HP-OCT (HP-OCT) received FDA 510(k) clearance on 2024-03-08, under 510(k) number K231760.
Who is the listed applicant for HP-OCT (HP-OCT)?
The FDA 510(k) record lists Cylite Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HP-OCT (HP-OCT)?
The FDA product code for HP-OCT (HP-OCT) is HJO.
列明Cylite Pty. , Ltd.为申报人的其他记录
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：HJO）
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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