CVAC吸引系统 + CVAC图像处理器
K号: K233472 · 2024-02-02
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申请人Calyxo, Inc.
决定日期2024-02-02
产品代码FED
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
CVAC Aspiration System + CVAC Image Processor is the device name listed in this FDA 510(k) record. The listed applicant is Calyxo, Inc.. It received FDA 510(k) clearance on 2024-02-02 under 510(k) number K233472. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CVAC Aspiration System + CVAC Image Processor?
CVAC Aspiration System + CVAC Image Processor is a medical device that received FDA 510(k) clearance on 2024-02-02. The listed applicant is Calyxo, Inc.. The 510(k) number is K233472.
When did CVAC Aspiration System + CVAC Image Processor receive FDA 510(k) clearance?
CVAC Aspiration System + CVAC Image Processor received FDA 510(k) clearance on 2024-02-02, under 510(k) number K233472.
Who is the listed applicant for CVAC Aspiration System + CVAC Image Processor?
FDA 510(k)记录显示Calyxo，Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for CVAC Aspiration System + CVAC Image Processor?
The FDA product code for CVAC Aspiration System + CVAC Image Processor is FED.
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。
列明Calyxo, Inc.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：FED）
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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