Aina HbA1c监测系统2
K号: K192987 · 2020-03-26
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决定日期2020-03-26
产品代码LCP
咨询委员会HE
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决定实质等同
器械摘要
Aina HbA1c Monitoring System 2 is the device name listed in this FDA 510(k) record. The listed applicant is Jana Care, Inc.. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K192987. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Aina HbA1c Monitoring System 2?
Aina HbA1c Monitoring System 2 is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Jana Care, Inc.. The 510(k) number is K192987.
When did Aina HbA1c Monitoring System 2 receive FDA 510(k) clearance?
Aina HbA1c Monitoring System 2 received FDA 510(k) clearance on 2020-03-26, under 510(k) number K192987.
Who is the listed applicant for Aina HbA1c Monitoring System 2?
The FDA 510(k) record lists Jana Care, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aina HbA1c Monitoring System 2?
The FDA product code for Aina HbA1c Monitoring System 2 is LCP.
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。
相关器械（代码：LCP）
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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