SomnoDent ALPHA
K号: K162306 · 2016-09-20
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决定日期2016-09-20
产品代码LRK
咨询委员会DE
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器械摘要
SomnoDent ALPHA is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed, Inc.. It received FDA 510(k) clearance on 2016-09-20 under 510(k) number K162306. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SomnoDent ALPHA?
SomnoDent ALPHA is a medical device that received FDA 510(k) clearance on 2016-09-20. The listed applicant is Somnomed, Inc.. The 510(k) number is K162306.
When did SomnoDent ALPHA receive FDA 510(k) clearance?
SomnoDent ALPHA received FDA 510(k) clearance on 2016-09-20, under 510(k) number K162306.
Who is the listed applicant for SomnoDent ALPHA?
The FDA 510(k) record lists Somnomed, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SomnoDent ALPHA?
The FDA product code for SomnoDent ALPHA is LRK.
相关临床试验
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列明Somnomed, 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：LRK）
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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