Hailie Sensor NF0107 & NF0108
K号: K221994 · 2022-10-04
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决定日期2022-10-04
产品代码CAF
咨询委员会AN
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决定实质等同
器械摘要
Hailie Sensor NF0107 & NF0108 is the device name listed in this FDA 510(k) record. The listed applicant is Adherium (Nz), Ltd.. It received FDA 510(k) clearance on 2022-10-04 under 510(k) number K221994. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Hailie Sensor NF0107 & NF0108?
Hailie Sensor NF0107 & NF0108 is a medical device that received FDA 510(k) clearance on 2022-10-04. The listed applicant is Adherium (Nz), Ltd.. The 510(k) number is K221994.
When did Hailie Sensor NF0107 & NF0108 receive FDA 510(k) clearance?
Hailie Sensor NF0107 & NF0108 received FDA 510(k) clearance on 2022-10-04, under 510(k) number K221994.
Who is the listed applicant for Hailie Sensor NF0107 & NF0108?
The FDA 510(k) record lists Adherium (Nz), Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hailie Sensor NF0107 & NF0108?
The FDA product code for Hailie Sensor NF0107 & NF0108 is CAF.
相关临床试验
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列明Adherium (Nz), 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：CAF）
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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