Elevo® 套件 呼吸干预设备
K号: K181107 · 2018-12-06
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决定日期2018-12-06
产品代码LRK
咨询委员会DE
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决定实质等同
器械摘要
Elevo® Kit Snoring Intervention Device is the device name listed in this FDA 510(k) record. The listed applicant is Zelegent, Inc.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K181107. 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 Elevo® Kit Snoring Intervention Device?
Elevo® Kit Snoring Intervention Device is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Zelegent, Inc.. The 510(k) number is K181107.
When did Elevo® Kit Snoring Intervention Device receive FDA 510(k) clearance?
Elevo® Kit Snoring Intervention Device received FDA 510(k) clearance on 2018-12-06, under 510(k) number K181107.
Who is the listed applicant for Elevo® Kit Snoring Intervention Device?
The FDA 510(k) record lists Zelegent, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Elevo® Kit Snoring Intervention Device?
The FDA product code for Elevo® Kit Snoring Intervention Device is LRK.
相关临床试验
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列明Zelegent, 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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