TruGuard 定制舌和颌位器
K号: K153270 · 2016-03-08
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器械摘要
TruGuard Custom Tongue and Jaw Positioner is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K153270. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TruGuard Custom Tongue and Jaw Positioner?
TruGuard Custom Tongue and Jaw Positioner is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Bionix Development Corp.. The 510(k) number is K153270.
When did TruGuard Custom Tongue and Jaw Positioner receive FDA 510(k) clearance?
TruGuard Custom Tongue and Jaw Positioner received FDA 510(k) clearance on 2016-03-08, under 510(k) number K153270.
Who is the listed applicant for TruGuard Custom Tongue and Jaw Positioner?
The FDA 510(k) record lists Bionix Development Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TruGuard Custom Tongue and Jaw Positioner?
The FDA product code for TruGuard Custom Tongue and Jaw Positioner is IYE.
相关临床试验
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相关器械（代码：IYE）
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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