ASD Oral Appliances
K号: K163580 · 2017-06-08
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决定日期2017-06-08
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
ASD Oral Appliances is the device name listed in this FDA 510(k) record. The listed applicant is American Sleep Dentistry. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K163580. 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 ASD Oral Appliances?
ASD Oral Appliances is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is American Sleep Dentistry. The 510(k) number is K163580.
When did ASD Oral Appliances receive FDA 510(k) clearance?
ASD Oral Appliances received FDA 510(k) clearance on 2017-06-08, under 510(k) number K163580.
Who is the listed applicant for ASD Oral Appliances?
The FDA 510(k) record lists American Sleep Dentistry as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ASD Oral Appliances?
The FDA product code for ASD Oral Appliances is LRK.
相关临床试验
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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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