Naya 乳房泵系统
K号: K160511 · 2016-06-24
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决定日期2016-06-24
产品代码HGX
咨询委员会OB
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决定实质等同
器械摘要
Naya Breast Pump System is the device name listed in this FDA 510(k) record. The listed applicant is Naya Health, Inc.. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K160511. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Naya Breast Pump System?
Naya Breast Pump System is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Naya Health, Inc.. The 510(k) number is K160511.
When did Naya Breast Pump System receive FDA 510(k) clearance?
Naya Breast Pump System received FDA 510(k) clearance on 2016-06-24, under 510(k) number K160511.
Who is the listed applicant for Naya Breast Pump System?
The FDA 510(k) record lists Naya Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Naya Breast Pump System?
The FDA product code for Naya Breast Pump System is HGX.
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：HGX）
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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