Luna CPAP 和自动 CPAP 系统
K号: K153387 · 2016-09-08
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决定日期2016-09-08
产品代码BZD
咨询委员会AN
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决定实质等同
器械摘要
Luna CPAP and Auto CPAP System is the device name listed in this FDA 510(k) record. The listed applicant is 3B Medical, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K153387. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Luna CPAP and Auto CPAP System?
Luna CPAP and Auto CPAP System is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is 3B Medical, Inc.. The 510(k) number is K153387.
When did Luna CPAP and Auto CPAP System receive FDA 510(k) clearance?
Luna CPAP and Auto CPAP System received FDA 510(k) clearance on 2016-09-08, under 510(k) number K153387.
Who is the listed applicant for Luna CPAP and Auto CPAP System?
The FDA 510(k) record lists 3B Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Luna CPAP and Auto CPAP System?
The FDA product code for Luna CPAP and Auto CPAP System is BZD.
相关临床试验
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列明3B Medical, Inc.为申报人的其他记录
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相关器械（代码：BZD）
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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