Novo
K号: K212361 · 2022-08-11
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申请人PathAI, Inc.
决定日期2022-08-11
产品代码QKQ
咨询委员会PA
请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
Novo is the device name listed in this FDA 510(k) record. The listed applicant is PathAI, Inc.. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K212361. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Novo?
Novo is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is PathAI, Inc.. The 510(k) number is K212361.
When did Novo receive FDA 510(k) clearance?
Novo received FDA 510(k) clearance on 2022-08-11, under 510(k) number K212361.
Who is the listed applicant for Novo?
The FDA 510(k) record lists PathAI, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Novo?
The FDA product code for Novo is QKQ.
列明PathAI, 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：QKQ）
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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